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  • 1
    Electronic Resource
    Electronic Resource
    GM-CSF, carboplatin, doxorubicin: a phase I study (1994)
    Springer
    Cancer chemotherapy and pharmacology 33 (1994), S. 340-346 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract. Dose intensification has the potential to increase the response frequency of chemosensitive tumors to chemotherapy. G-CSF and GM-CSF offer the possibility of dose-intensifying chemotherapy without prohibitive myelosuppression. A phase I study was undertaken to identify the maximum tolerated dose (MTD) of carboplatin that could be administered with a fixed dose of doxorubicin, 60 mg/m2, administered every 28 days. Further escalation of the carboplatin dose was then attempted, with the concomitant addition of GM-CSF 10 mg/kg per day on days 1 – 21. We had 21 patients, 13 with prior therapy, who were eligible. In all, 60 courses of therapy were delivered, all with doxorubicin and with carboplatin doses of 250 mg/m2, 325 mg/m2 and 400 mg/m2. At carboplatin 400 mg/m2 and doxorubicin 60 mg/m2, thrombocytopenia was dose limiting. The addition of GM-CSF did not allow further escalation. Of the 6 patients treated with carboplatin 400 mg/m2, doxorubicin 60 mg/m2, and GM-CSF, grade 4 granulocytopenia and thrombocytopenia were seen in 4 and 5 patients, respectively. The severity of thrombocytopenia was related to the calculated carboplatin AUC and also to baseline platelet count and prior therapy. In addition, the interaction of GM-CSF and chemotherapy, especially carboplatin-based, may be more complex than originally anticipated.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00685910
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  • 2
    Electronic Resource
    Electronic Resource
    GM-CSF, carboplatin, doxorubicin: a phase I study (1994)
    Springer
    Cancer chemotherapy and pharmacology 33 (1994), S. 340-346 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Dose intensification has the potential to increase the response frequency of chemosensitive tumors to chemotherapy. G-CSF and GM-CSF offer the possibility of dose-intensifying chemotherapy without prohibitive myelosuppression. A phase I study was undertaken to identify the maximum tolerated dose (MTD) of carboplatin that could be administered with a fixed dose of doxorubicin, 60 mg/m2, administered every 28 days. Further escalation of the carboplatin dose was then attempted, with the concomitant addition of GM-CSF 10 mg/kg per day on days 1–21. We had 21 patients, 13 with prior therapy, who were eligible. In all, 60 courses of therapy were delivered, all with doxorubicin and with carboplatin doses of 250 mg/m2, 325 mg/m2 and 400 mg/m2. At carboplatin 400 mg/m2 and doxorubicin 60 mg/m2, thrombocytopenia was dose limiting. The addition of GM-CSF did not allow further escalation. Of the 6 patients treated with carboplatin 400 mg/m2, doxorubicin 60 mg/m2, and GM-CSF, grade 4 granulocytopenia and thrombocytopenia were seen in 4 and 5 patients, respectively. The severity of thrombocytopenia was related to the calculated carboplatin AUC and also to baseline platelet count and prior therapy. In addition, the interaction of GM-CSF and chemotherapy, especially carboplatin-based, may be more complex than originally anticipated.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00685910
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    A phase II trial of diaziquone in patients with head and neck cancer (1987)
    Springer
    Cancer chemotherapy and pharmacology 19 (1987), S. 265-268 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Diaziquone (AZQ) is a lipophilic alkylating agent which crosses the blood-brain barrier and has marked antitumor activity in a broad spectrum of murine tumor systems. Myelosuppression has been the dose-limiting toxicity in phase I trials. In this study 36 patients with head and neck cancer received diaziquone. Thirty-one of these patients (28 male, 3 female) were evaluable for efficacy. The initial starting dose was 7 mg/m2/dayx5 days i. v. repeated every 28 days. Because of the severe myelosuppression encountered in the first four patients, the starting dose was decreased by 20% to 5.5 mg/m2/dayx5 days repeated every 28 days. The majority of patients were considered to be good-risk patients as evidenced by performance status (80% 0–1 Zubrod) and prior therapy. Even with this dosage reduction, myelosuppression (especially thrombocytopenia) was again the dose-limiting toxicity with 25% of patients experiencing granulocyte and platelet nadirs below 1000/mm3 and 50000/mm3 respectively. Thirty-five percent of patients required a subsequent dosage reduction of 20% prior to receiving a second course of therapy. There was one complete (CR), four patial (PR) and three minor (MR) responses. All but the CR were of relatively short duration (mean of 30 days). The patient with a CR has remained disease-free for nearly 3 years. In this group of patients the activity of diaziquone as a single agent at this dose and schedule (CR+PR+MR=26%; CR+PR=16%) is less than that of methotrexate, bleomycin, and cis-platinum but is encouraging. Further trials utilizing combinations are warranted.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00252985
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  • 4
    Electronic Resource
    Electronic Resource
    Phase I/II trial of high dose mitoxantrone in metastatic breast cancer: the M.D. Anderson Cancer Center experience (1999)
    Springer
    Breast cancer research and treatment 54 (1999), S. 225-233 
    Details
    ISSN: 1573-7217
    Keywords: cardiac toxicity ; dose intensity ; metastatic breast cancer ; mitoxantrone ; myelosuppression ; single agent chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Anthracyclines are among the most active agents in metastatic breast cancer. Mitoxantrone demonstrated a different toxicity profile when compared to doxorubicin. We performed a phase I/II study of single‐agent high‐dose mitoxantrone therapy for advanced breast cancer. Nineteen patients who had a diagnosis of metastatic breast cancer received treatment at the M.D. Anderson Cancer Center between June 1986 and December 1987. The patients received escalating doses of mitoxantrone until a maximum tolerated dose (MTD), defined as grade 3 or 4 nonhematologic toxicity or infection, was obtained. The starting dose of 25 mg/m2, given by short intravenous infusion, was escalated by 25% in each five‐patient cohort if each patient in the previous cohort tolerated the initial course and 2 or fewer patients reached the MTD. The median cumulative dose of mitoxantrone was 93 mg/m2 (range, 25–205) and the maximum single dose was 39 mg/m2. Myelosuppression was the dose limiting toxicity. The median duration of granulocyte count ≤ 250/μl was 5–7 days. Four patients (22%) had infections that required hospitalization, 3 patients (17%) had cardiac toxicity. One patient (6%) achieved a complete response, and 3 (17%) had a partial response, with an overall response rate of 22.3%. No apparent dose‐response relationship was observed in our study. The mitoxantrone dosage recommended for phase II studies is 25 mg/m2 every 3–4 weeks. We conclude that high‐dose mitoxantrone therapy for metastatic breast cancer was relatively well tolerated but was not associated with a higher response rate than that of standard dose mitoxantrone.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006104610727
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  • 5
    Electronic Resource
    Electronic Resource
    Phase II study of pibenzimol in pancreatic cancer (1991)
    Springer
    Investigational new drugs 9 (1991), S. 95-96 
    Details
    ISSN: 1573-0646
    Keywords: pibenzimol in pancreatic cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twenty-three patients with advanced pancreatic adenocarcinoma were treated with Pibenzimol utilizing a daily intravenous schedule for five days. There were no objective responses seen. The major toxicity was pancreatic with grade 3 hyperglycemia in eleven patients. Pibenzimol is inactive in patients with advanced pancreatic adenocarcinoma.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194556
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  • 6
    Electronic Resource
    Electronic Resource
    Mitoxantrone in advanced breast cancer: a phase II trial of the Southwest Oncology Group (1983)
    Springer
    Investigational new drugs 1 (1983), S. 181-184 
    Details
    ISSN: 1573-0646
    Keywords: mitoxantrone ; breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary 124 patients with metastatic breast cancer were entered into this phase II trial of mitoxantrone (DHAD). Patients were stratified prior to treatment as good or poor risk, and whether they had received previous therapy with an anthracycline derivative. Mitoxantrone was given every 21 days at a starting dose of 12 mg/m2 for good risk patients and 10 mg/m2 for poor risk patients. Among the group who had not received anthracyclines, 12 are fully or partially evaluable for response with five classified as good risk. One complete response, ongoing at 52 weeks was seen in this group. Of the seven poor risk patients, stable disease was seen in two. 103 patients with prior anthracycline exposure are fully or partially evaluable, 31 good risk and 72 poor risk. There were three partial responses in each group. Toxicity was primarily myelosuppression, and was more severe in the poor risk group. Mitoxantrone when used on this schedule has minimal activity among heavily pretreated patients with metastatic breast cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00172078
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  • 7
    Electronic Resource
    Electronic Resource
    Phase II study of L-alanosine (NSC 153353) in patients with advanced breast cancer (1991)
    Springer
    Investigational new drugs 9 (1991), S. 87-88 
    Details
    ISSN: 1573-0646
    Keywords: phase II ; L-alanosine ; breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194553
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  • 8
    Electronic Resource
    Electronic Resource
    Effect of 2,3-dihydro-1H-imidazo [1,2-b]pyrazole (IMPY) on the metabolism of human red cells (1983)
    Springer
    Investigational new drugs 1 (1983), S. 243-248 
    Details
    ISSN: 1573-0646
    Keywords: red cells ; IMPY ; oxidation ; HMPS ; glutathione
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary 2,3 dihydro-IH-imidazo (1,2-b) pyrazole (IMPY) is a potential chemotherapeutic agent known to inhibit cellular DNA synthesis by blocking ribonucleotide reductase. During Phase I clinical studies with IMPY, patients developed a dose dependent hemolytic anemia possibly secondary to oxidant damage to the RBC. We therefore studied the effect of IMPY on the metabolism of human RBC's in vitro. IMPY, in clinically achievable concentrations, stimulated the hexose monophosphate shunt (HMPS) pathway of RBC's. This was associated with the generation of reactive oxygen species as demonstrated by the glutathione (GSH) instability and enhanced formate oxidation of RBC's incubated with the drug. In addition, the GSH concentration of the red cells of a patient fell during a continuous infusion of IMPY. These effects of IMPY on red cell metabolism in vitro and in vivo are similar to those of drugs known to cause oxidative damage to this cell. The capacity of IMPY to act as an oxidant could explain the hemolytic anemia seen in patients receiving this drug.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00208897
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  • 9
    Electronic Resource
    Electronic Resource
    A randomized trial of doxorubicin, mitoxantrone and bisantrene in advanced breast cancer (A South West Oncology Group Study) (1985)
    Springer
    Investigational new drugs 3 (1985), S. 149-152 
    Details
    ISSN: 1573-0646
    Keywords: breast cancer ; chemotherapy ; doxorubicin ; mitoxantrone ; bisantrene
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary New agents with increased activity and/or reduced toxicity are needed for the treatment of advanced breast cancer. The anthracene derivatives mitoxantrone and bisantrene had significant activity and acceptable toxicity in phase II trials. In an ongoing phase III trial we have now randomized 150 patients with advanced breast cancer to either doxorubicin (60 mg/m2), mitoxantrone (14 mg/m2) or bisantrene (260 mg/m2) i.v. q 3 weeks with re-randomization for cross-over at the time of progression to determine the relative efficacy and toxicity of these three agents. To be eligible, patients must have had only one previous chemotherapy regimen. ER positive patients must have failed endocrine therapy. Patients with CHF or severe cardiac disease were ineligible. In this preliminary evaluation, 117 patients are evaluable for response and 110 for toxicity. Median age for all patients is 58 years (range 26–78). The majority (86%) are postmenopausal. Fifty-nine percent of the patients have visceral dominant disease. Estrogen receptor is positive in 37%, negative in 39% and unknown in 24% of patients. Median performance status (SWOG) is 1, range 0–2. Objective responses have been observed on each arm (doxorubicin 9/35, mitoxantrone 6/38, bisantrene 6/44). Thirty-two patients are evaluable for cross-over response (doxorubicin 2/13, mitoxantrone 1/11, bisantrene 0/8). The predominant toxicity is leukopenia with a nadir WBC count 〈2000 in 45% of all courses administered. Leukopenia is similar with the three drugs. Significant nausea, vomiting and alopecia are common with doxorubicin and uncommon with the other agents. Congestive heart failure has been observed in one patient (doxorubicin). Definitive conclusions regarding the efficacy and toxicity of these agents await the completion of this trial.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00174162
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  • 10
    Electronic Resource
    Electronic Resource
    Dose-intensive treatment of breast cancer supported by granulocyte-macrophage colony-stimulating factor (GM-CSF) (1991)
    Springer
    Breast cancer research and treatment 20 (1991), S. S15 
    Details
    ISSN: 1573-7217
    Keywords: breast cancer ; dose-intensive therapy ; G-CSF ; GM-CSF ; hematopoietic toxicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Substantial intensification of chemotherapy doses is a promising approach to the treatment of refractory malignancy currently receiving increasing attention. For the past 4 years we have used 3 repeated cycles of a combination of cyclophosphamide (5 g/m2), etoposide (1500 mg/m2), and cisplatin (150 mg/m2) without replacement of progenitor cells and with and without colony-stimulating factor support. The duration of threatening levels of granulocytopenia with this regimen averages 10.2 days, although an occasional patient has prolonged recovery (range, 5–20 days) and most patients require antibiotic therapy for cytopenic fever. We have not yet identified the optimal dose of GM-CSF, but 500 µg/m2 significantly shortens the duration of cytopenia (ANC 〈 300/mm3) to 5.9 days with a resultant decrease in incidence and duration of cytopenic fever (from 10.8 to 1.7 days), use of antibiotics (from 10.8 to 7.6 days), and duration of hospitalization (from 22.2 to 16.3 days). Seventeen patients with metastatic breast cancer have received this regimen to date with a 35% complete response (CR) rate and a 53% partial response (PR) rate. Most of these patients were refractory to standard therapy. Four of six (67%) not refractory to standard therapy have achieved complete responses that are ongoing at 3.5 to 10.4 months. We conclude that dose-intensive therapy is an option that needs more careful exploration early in the treatment of advanced breast cancer and that GM-CSF decreases morbidity and risk of dose-intensive regimens.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01908240
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