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  • 1
    Electronic Resource
    Electronic Resource
    Phase II study of recombinant human interleukin 3 administration following carboplatin and etoposide chemotherapy in small-cell lung cancer patients (1996)
    Springer
    Cancer chemotherapy and pharmacology 38 (1996), S. S89 
    Details
    ISSN: 1432-0843
    Keywords: Key words Recombinant human interleukin 3 (rhIL-3) ; Thrombocytopenia ; Chemotherapy ; Small-cell lung cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Recombinant human interleukin 3 (rhIL-3) has been suggested to be a useful agent for the treatment of chemotherapy-induced thrombocytopenia. For evaluation of this possibility, rhIL-3 was given subcutaneously for 10 days to patients with small-cell lung cancer (SCLC). Chemotherapy consisted of carboplatin (CBDCA) given at 400 mg/m2 to previously untreated patients or at 350 mg/m2 to previously treated patients on day 1 and etoposide (VP-16) given at 100 mg/m2 on days 1 – 3 every 4 weeks. If the platelet count nadir was 〈75,000/μl in the control cycle of chemotherapy, patients were randomly assigned for the next cycle to rhIL-3 given at 5 or 10 μg/kg per day on days 4 – 13. A total of 41 patients (32 previously untreated patients and 9 previously treated patients) were enrolled in the study. The platelet count nadir in the cycles including rhIL-3 was significantly higher at both dose levels (P〈0.01) than in the control cycle. The duration of thrombocytopenia (〈75,000/μl) and the mean time from the 1st day of chemotherapy to thrombocyte recovery (〉100,000/μl) in the rhIL-3 cycle were significantly shorter than those in the control cycle (P〈0.01). The neutrophil count nadir and the duration of neutropenia (〈1,000/μl) were also significantly improved in the rhIL-3 cycle (P〈0.05). The major side effects were fever (80.5%), headache (24.3%), and fatigue (14.6%). All side effects were tolerable and of less than grade II. There was no difference in the efficacy of the two dose levels, but the 5-μg/kg dose appeared to be better tolerated than the 10-μg/kg dose. We conclude that rhIL-3 administration following chemotherapy consisting of CBDCA and VP-16 reduces the incidence and severity of chemotherapy-induced thrombocytopenia and neutropenia with an acceptable adverse-events profile.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800051046
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  • 2
    Electronic Resource
    Electronic Resource
    Dose-intensive chemotherapy in extensive-stage small-cell lung cancer (1997)
    Springer
    Cancer chemotherapy and pharmacology 40 (1997), S. S70 
    Details
    ISSN: 1432-0843
    Keywords: Key words Extensive-stage small-cell lung cancer ; Dose intensity ; CODE chemotherapy ; rhG-CSF
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  The importance of the dose intensity of chemotherapy in achieving maximal therapeutic effect has recently been reported for several chemosensitive malignant diseases, with Murray et al. reporting that intensive weekly chemotherapy using the cisplatin, vincristine, doxorubicin, and etoposide (CODE) regimen in small-cell lung cancer (SCLC) is very effective. However, leukopenia is the major obstacle to delivering the planned dose in intensive regimens. Therefore, we investigated whether recombinant human granulocyte colony-stimulating factor (rhG-CSF) could allow full drug doses to be given as scheduled, thereby improving the final outcome. Extensive-stage (ES) SCLC patients were randomized to receive either CODE alone or CODE with rhG-CSF, with the CODE regimen consisting of cisplatin given i.v. at 25 mg/m2 weekly for 9 weeks; vincristine given i.v. at 1 mg/m2 during weeks 1, 2, 4, 6, and 8; and doxorubicin given i.v. at 40 mg/m2 and etoposide given i.v. at 80 mg/m2 for 3 days during weeks 1, 3, 5, 7, and 9. rhG-CSF at 50 μg/m2 was given s.c. on the days on which cytotoxic drugs were not given. From May 1989 to September 1991, 64 patients were enrolled in the study, of whom 63 were analyzable (31 for CODE alone and 32 for CODE with rhG-CSF). No difference in any of the patients’ characteristics except gender was found between the two groups. The complete response (CR) rate was 34% in the CODE with rhG-CSF group and 23% in the CODE alone group; the median survival was 59 and 32 weeks, respectively, in these groups (P = 0.004). Therefore CODE with rhG-CSF improved the survival of ES SCLC patients. On the basis of these results a phase III study to determine whether CODE with rhG-CSF would increase survival as compared to the standard regimen in ES SCLC was designed by the Japan Clinical Oncology Group.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800051065
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  • 3
    Electronic Resource
    Electronic Resource
    The use of granulocyte colony-stimulating factor to shorten the interval between cycles of mitomycin C, vindesine, and cisplatin chemotherapy in non-small-cell lung cancer (1992)
    Springer
    Cancer chemotherapy and pharmacology 31 (1992), S. 182-186 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary We investigated the possibility of shortening the interval between courses of the commonly prescribed 28-day MVP (mitomycin C, vindesine, and cisplatin) regimen in patients with non-small-cell lung cancer (NSCLC). We conducted a nonrandomized phase II study using recombinant human granulocyte colony-stimulating factor (G-CSF, Chugai) to explore the possibility of shortening the cycle length to 21 days and compared the results with those obtained in historical controls who had received the standard 28-day regimen. A total of 40 patients, 37 of whom were evaluable, were entered in the 21-day treatment group of the trial and were compared with 38 historical controls who had received standard 28-day cycles of MVP at our institution. Patients in the 21-day group received mitomycin C at 8 mg/m2 on day 1, vindesine at 3 mg/m2 on days 1 and 8, and cisplatin at 80 mg/m2 on day 1, with the schedule being repeated every 21 days. Controls had received the same regimen, albeit at 28-day intervals. G-CSF was given s. c. to the patients in the 21-day group at a daily dose of 2 μg/kg from day 2 to day 21 of every MVP cycle. The administration of G-CSF to these patients accelerated neutrophil recovery as compared with that observed in the historical controls. Significant differences were found between the two groups in terms of mean neutrophil nadirs (2666/μl in the first cycle and 1369/μl in the second for the G-CSF group vs 416/μl in the first cycle and 685/μl in the second cycle for the control group;P〈0.0001) and the mean duration of neutropenia (≤1000/μl; 1.0 day in the first cycle and 1.7 days in the second for the G-CSF group vs 8.0 days in the first cycle and 6.9 days in the second for the control gruop;P〈0.0001). This enabled 32 (86%) of 37 patients in the G-CSF group to complete ≥2 cycles on schedule. In 10 patients, the bone marrow aspirates taken after G-CSF administration showed increases in band neutrophil and myelocyte percentages. In conclusion, MVP treatment of patients with NSCLC at 21-day intervals is possible with the support of G-CSF.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00685545
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  • 4
    Electronic Resource
    Electronic Resource
    Cisplatin-based combination chemotherapy for elderly patients with non-small-cell lung cancer (1997)
    Springer
    Cancer chemotherapy and pharmacology 40 (1997), S. 469-474 
    Details
    ISSN: 1432-0843
    Keywords: Key words Non-small-cell lung cancer ; Elderly ; Chemotherapy ; Cisplatin ; Mitomycin-C
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: To compare the response rates, toxicities and survival durations of elderly patients (70 years of age or more) with those of younger patients ( less than 70 years of age) with non-small-cell lung cancer (NSCLC) treated with cisplatin-based chemotherapy. Patients and methods: We analyzed retrospectively the data of 203 assessable patients entered on a prospective randomized trial of cisplatin-based combination chemotherapy. Chemotherapy consisted of three dosage regimens: (1) vindesine and cisplatin (VP); (2) mitomycin, vindesine and cisplatin (MVP); or (3) etoposide and cisplatin alternating with vindesine and mitomycin (EP/VM). Results: A greater proportion of elderly patients had localized disease and more squamous cell carcinoma than non-elderly patients. The overall response rates were 44% in the elderly group and 28% in the non-elderly group. In the EP/VM arm, the response rate was significantly better in the elderly group than in the non-elderly group. The frequency of grade 4 leukocytopenia in the MVP and EP/VM arms in the elderly group was significantly greater than in the non-elderly group (P 〈 0.05). No differences were found in nonhematological toxicities between the two groups. There was no difference in overall survival between the groups. Conclusion: Elderly patients treated with mitomycin-containing regimens have higher hematologic toxicities than younger patients. The results of this study are consistent with the previously reported pharmaco logic data on mitomycin suggesting altered pharmacokinetics in elderly patients. The improved response rate in the elderly patients was probably because more elderly patients had earlier disease, squamous cell carcinoma and better performance status. Cisplatin-based chemotherapy was tolerable for most elderly NSCLC patients with good performance status.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050689
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  • 5
    Electronic Resource
    Electronic Resource
    Activity of gemcitabine in non-small-cell lung cancer: results of the Japan gemcitabine group (A) phase II study (1997)
    Springer
    Cancer chemotherapy and pharmacology 41 (1997), S. 217-222 
    Details
    ISSN: 1432-0843
    Keywords: Key words Gemcitabine ; NSCLC ; Phase II ; Japan
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: This phase II study was conducted to determine the response and toxicity of gemcitabine (2′,2′-difluorodeoxycytidine) in chemotherapy-naive patients with non-small-cell lung cancer (NSCLC). Methods: A group of 73 patients were entered into the study. The patients had received no previous chemotherapy and all had measurable disease. The initial starting dose of gemcitabine was 1000 mg/m2 per week × 3 followed by a week of rest, and was escalated for the next cycle to 1250 mg/m2, provided there were no signs of hematologic toxicity (WBC〈3000/μl and/or platelets 〈 70 000/μl) in the previous cycle. Results: Among 73 eligible patients, there were 19 partial responses (PRs), with an overall response rate of 26.0% (95% confidence interval 16.5–37.6%). The response rate for stage IIIa and IIIb disease was significantly higher than that for stage IV disease [41.4% (12/29) vs 15.9% (7/44); P = 0.028]. The median duration of response in patients showing a PR was 4.6 months (1.7–10.4 months). The median number of cycles given was two per patient (range one to seven). Grade 3 anemia, leukopenia and neutropenia occurred in 15 patients (20.5%), 7 patients (9.6%) and 20 patients (27.4%), respectively. Grade 3 thrombocytopenia occurred in one patient (1.4%) which was not associated with any bleeding. There was no evidence of cumulative toxicity in the later courses of gemcitabine treatment with regard to leukopenia and thrombocytopenia. Other toxicities, including hepatic toxicity, fatigue, nausea/vomiting and fever were mild (grade 2 or less) and transient. One patient was withdrawn from the trial because of a rash. Pulmonary toxicity was experienced in two patients and one patient died of respiratory insufficiency which was thought to be drug-related. Conclusions: Gemcitabine as a single agent has proven to be an active drug for NSCLC with a favorable, generally mild side-effect profile. Further trials in combination with other agents for this disease are currently underway.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050731
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  • 6
    Electronic Resource
    Electronic Resource
    Phase I study of E7010 (1998)
    Springer
    Cancer chemotherapy and pharmacology 42 (1998), S. 127-134 
    Details
    ISSN: 1432-0843
    Keywords: Key words E7010 ; Sulfonamide ; Antimitotic agent ; Phase I study ; Pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract E7010 is a novel sulfonamide which was discovered using slow-growing colon 38 carcinoma cells as a screening model. E7010 exhibits a broad spectrum of antitumor activity against human tumor xenografts. The mechanism of action is by arresting the progression of cells in M phase of the cell cycle by inhibiting tubulin polymerization. The objective of this phase I study was to determine the maximum allowable dose (MAD), toxicity, and pharmacokinetics of single or 5-day repeated doses of E7010. In the single-dose study, E7010 was administered orally to 16 patients at doses ranging from 80 to 480 mg/m2. The dose-limiting toxicity was peripheral neuropathy at a dose of 480 mg/m2. Hematological and gastrointestinal toxicities were mild. In the 5-day repeated-dose study, 41 patients were given E7010 at doses ranging from 30 to 240 mg/m2 per day. The dose-limiting toxicities were peripheral neuropathy and intestinal paralysis. Gastrointestinal toxicity was dose-dependent but not severe. Hematological toxicity was not dose-dependent. Pharmacokinetic analysis in the single-dose study showed a rapid increase in the plasma levels of the drug after administration, followed by disappearance with a t1/2 of 4.4–16.6 h. The variation in area under the plasma concentration-time curve (AUC) between the patients was small and increased in a dose-dependent manner. Total drug recovery in urine 72 h after administration was 77.8 ± 11.4%, indicating that E7010 has favorable absorption and elimination profiles. The changes in the plasma levels of E7010 on day 5 in the 5-day repeated-dose study were almost the same as those on day 1, indicating that the drug did not accumulate. In the single-dose study, spinal cord metastasis exhibited a 74% reduction in a patient with uterine sarcoma and a minor response (MR) was observed in a pulmonary adenocarcinoma patient. In the 5-day repeated-dose study decreases in the tumor markers carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCC) were observed in a patient with stomach cancer and in a patient with recurrent uterine cervical carcinoma, respectively. The recommended phase II doses are 320 mg/m2 for a single-dose study and 200 mg/m2 per day for a 5-day repeated-dose study. Since the activity of E7010 is time-dependent, i.e. a certain concentration of E7010 is required for more than 12 h to suppress the growth of P388 leukemia cells, it is recommended that subsequent phase I/II studies be conducted using a divided dose schedule in order to maintain the blood level of E7010.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050795
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  • 7
    Electronic Resource
    Electronic Resource
    Clinical studies of irinotecan alone and in combination with cisplatin (1994)
    Springer
    Cancer chemotherapy and pharmacology 34 (1994), S. S105 
    Details
    ISSN: 1432-0843
    Keywords: Irinotecan ; Lung cancer ; Clinical studies
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Irinotecan (CPT-11), a new derivative of camptothecin, showed schedule-dependent antitumor activity and toxicity in preclinical animal studies. We carried out a phase I study of weekly CPT-11 infusion, which indicated that the recommended dose for phase II studies was 100 mg/ m2. In a phase II trial, CPT-11 achieved a response rate of 32% for non-small cell lung cancer (NSCLC). In two phase II trials, CPT-11 achieved objective response rates of 37% and 47% for small cell lung cancer (SCLC). The high activity of CPT-11 in these phase II studies suggested that the next rational step was to investigate combination chemotherapy. The first phase I trial of CPT-11 combined with cisplatin achieved an encouraging response rate of 54% in 27 patients with previously untreated NSCLC, and the recommended schedule for phase II studies was 60 mg/m2 of CPT-11 (days 1, 8, and 15) plus 80 mg/m2 of cisplatin (day 1) given at 4-week intervals. Given the high single-agent activity of CPT-11 against SCLC and NSCLC, a regimen with a higher dose of this agent and a lower dose of cisplatin seemed likely to be more effective. In the second trial, the cisplatin dose was accordingly reduced from 80 to 60 mg/m2, and the recommended dose of CPT-11 was concluded to be 80 mg/m2. Thus, reduction of the cisplatin dose to 60 mg/m2 allowed the safe administration of CPT-11 at 80 mg/m2 (33.3% dose intensification compared with the original regimen). The most recent trial of this combination with recombinant human granulocyte colony-stimulating factor (rhG-CSF) support demonstrated that the recommended dose is 80 mg/m2 of CPT-11 and 80 mg/m2 of cisplatin. Thus, we could raise the CPT-11 dose 33% above that given in the original regimen while maintaining the original cisplatin dose by the use of rhG-CSF support. Further trials are needed to evaluate the effect of CPT-11 given in combination with other active agents for the treatment of lung cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00684873
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  • 8
    Electronic Resource
    Electronic Resource
    Differential expressions of cyclin A and the retinoblastoma gene product in histological subtypes of lung cancer cell lines (1997)
    Springer
    Journal of cancer research and clinical oncology 123 (1997), S. 533-538 
    Details
    ISSN: 1432-1335
    Keywords: Key words Lung cancer ; NSCLC ; SCLC ; Cyclin A ; Retinoblastoma gene ; RB ; Immunoblotting
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Cell-cycle-dependent phosphorylation of the tumor-suppressor protein product of the retinoblastoma gene (RB) is mediated by a family of cyclin-dependent kinases and cyclins. We examined the expressions of RB protein and cyclin A protein in 13 small-cell lung cancer (SCLC) lines and 14 non-small-cell lung cancer (NSCLC) lines by immunoblotting. RB protein was not present or was of a mutant type in 77% of the SCLC lines (10/13) but was present in all the NSCLC lines. Cyclin A was expressed in 38% of the SCLC lines (5/13) and in 86% of the NSCLC lines (12/14). A positive correlation (P = 0.0034) between expression of cyclin A and wild-type RB protein was found by Fisher's exact probability test. Densitometric analysis of the expression of RB protein in RB(+) lung cancer lines showed that the phosphorylated form was predominant in 2/3 of the SCLC and 8/14 of the NSCLC lines. The positive correlation between the expressions of RB protein and cyclin A suggests that RB protein in most RB(+) lung cancer cell lines is a target of cyclin-A-dependent kinase and that the tumor-suppressor function may be inactivated by phosphorylation.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s004320050101
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  • 9
    Electronic Resource
    Electronic Resource
    Placebo-controlled double-blind comparative study on the preventive efficacy of mesna against ifosfamide-induced urinary disorders (1991)
    Springer
    Journal of cancer research and clinical oncology 117 (1991), S. 473-478 
    Details
    ISSN: 1432-1335
    Keywords: Mesna ; Ifosfamide ; Urinary disorders ; Placebo-controlled double ; Blind comparative study
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary In order to evaluate the preventive efficacy, safety and usefulness of mesna (Sodium 2-mercaptoethane sulfonate) against ifosfamide-induced urinary disorders, a placebo-controlled double-blind comparative study was performed. Ifosfamide was administered by intravenous drip infusion at a daily dose of 2 g/m2 for 5 consecutive days, and mesna was intravenously administered at 20% of the ifosfamide dose, three times daily for 5 consecutive days. The results obtained are as follows. (a) Of 101 accrued patients, 91 patients were evaluated consisting of 45 for the mesna group and 46 for the placebo group. There was no intergroup difference in the number of the evaluated cases and patient characteristics. (b) Micturition pain and feeling of residual urine graded as moderate or severe were not observed for the mesna group, but were observed for the placebo group with incidences of 19.6% (9/46) for micturition pain and 15.2% (7/46) for feeling of residual urine; the intergroup differences in the appearance of these urinary symptoms were statistically significant (P=0.0003 for micturition pain;P=0.0009 for feeling of residual urine). The incidence of hematuria graded as moderate or severe was 6.7% (3/45) in the mesna group, which was significantly lower than the 32.6% (15/46) in the placebo group (P=0.0008). (c) No side-effect attributable to mesna was observed. (d) A judgment of “useful” was obtained in 80.0% (36/45) of the patients treated with mesna, which was significantly higher than the 34.8% (16/46) of the patients treated with placebo (P= near 0). On the basis of the above results, we conclude that the preventive efficacy, safety and usefulness of mesna against ifosfamide-induced urinary disorders have been well demonstrated in this study.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01612769
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  • 10
    Electronic Resource
    Electronic Resource
    Phase I and pharmacologic study of oral (E)-2′-deoxy-2′-(fluoromethylene) cytidine: on a daily × 5-day schedule (1998)
    Springer
    Investigational new drugs 16 (1998), S. 245-254 
    Details
    ISSN: 1573-0646
    Keywords: phase I trial ; ribonucleoside diphosphate reductase inhibitor ; deoxytidine analog ; FMdC
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract (E)-2′-deoxy-2′-(fluoromethylene)cytidine (FMdC), one of the most potent inhibitors of ribonucleoside diphosphate reductase, was selected for clinical development because of its novel mechanisms of action, and strong antitumor activity against experimental tumor models. This study was designed to determine the toxicities, maximum-tolerated dose (MTD), and pharmacokinetic profile of FMdC. FMdC was given orally for 5 consecutive days every 3 or 4 weeks in patients with advanced solid tumors. The starting dose was 8 mg/m2/day. Pharmacokinetic studies were carried out on days 1 through 5 of the first cycle. Ten patients with non-small cell lung cancer received 15 courses of FMdC at doses which were de-escalated from 8 mg/m2/day to 2 mg/m2/day because of unexpected severe toxicities at the starting dose level. Neutropenia was the dose-limiting toxicity. Thrombocytopenia and anemia were mild. Flu-like symptoms and fever were the common non-hematologic toxicities. The MTD was 4 mg/m2/day, since four of six patients developed grade 3–4 neutropenia. At the 4 mg/m2/day dose level, the mean terminal half-life, maximum plasma concentration (Cmax), plasma clearance, and mean residence time on day 1 were 3.20 h, 15.8 ng/ml, 2.91 l/h/kg, and 4.03 h, respectively. The recommended dose for phase II studies with this schedule is also 4 mg/m2/day for 5 days. Further investigations are necessary to establish optimal dosing schedules and routes for the administration of FMdC.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006126212481
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