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  • 1
    Electronic Resource
    Electronic Resource
    Local Toxicity Patterns Associated with lntravesical bacillus Calmette-Guérin: A Southwest Oncology Group Study (1996)
    Oxford, UK : Blackwell Publishing Ltd
    International journal of urology 3 (1996), S. 0 
    Details
    ISSN: 1442-2042
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background: While the efficacy of bacillus Calmette-Cuérin (BCG) immunotherapy has been demonstrated, the relative benefit, given a seemingly high incidence and severity of toxicities, remains an issue. Adequate understanding and management of toxicities can maximize the safety of the treatment and enable the administration of required doses of BCC intravesical therapy. Methods: All week-to-week symptoms recorded for the 143 immunotherapy-naive participants assigned to the BCG arm of SWOG-8216, BCG vs. Doxorubicin in Superficial Bladder Cancer were analyzed in order to document the pattern of toxicities in the first six week induction course of intravesical BCC treatments. The statistical analysis consisted of fitting logistic regression models to these data for the probability of irritative bladder symptoms (16s). Results: In the optimal model, the probability of IBS depends only on whether there was IBS associated with the previous treatment, and not on which treatment. The estimated probability of having IBS when there were no 16s associated with the previous instillation is 0.136, whereas the estimated probability of having IBS when there was IBS associated with the previous instillation is 0.689. Conclusions: Irritative bladder symptoms are unlikely in the week after the first intravesical BCG treatment. Once a patient experiences IBS, he or she is more likely to have IBS with the next and subsequent treatments. Clinicians can use the findings of this analysis when informing their patients about the treatment course and when making decisions about continuing treatments.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1442-2042.1996.tb00490.x
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  • 2
    Electronic Resource
    Electronic Resource
    Metastatic prostate cancer (1990)
    Springer
    World journal of urology 8 (1990), S. 34-39 
    Details
    ISSN: 1433-8726
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary For decades the palliation of prostate cancer has centered around hormonal manipulation using orchiectomy or estrogen administration. Newer modalities, such as LHRH agonists and nonsteroidal antiandrogens, are now available. Patients receiving combination therapy enjoy superior progression-free and median survival rates.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01576275
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  • 3
    Electronic Resource
    Electronic Resource
    Phase II evaluation of didemnin B in hormonally refractory metastatic prostate cancer (1995)
    Springer
    Investigational new drugs 13 (1995), S. 167-170 
    Details
    ISSN: 1573-0646
    Keywords: prostate cancer ; phase II ; didemnin B
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Didemnin B, a dipsipeptide isolated from the Caribbean tunicate Trididemnum with antitumor and antiviral activity was evaluated in a phase II trial in the treatment of metastatic, hormonally refractory adenocarcinoma of the prostate. Thirteen patients were treated with didemnin B at 3.5 mg/m2 and 20 patients were treated at 6.3 mg/m2 intravenously every 28 days. Response was assessed every 8 weeks. Of 32 evaluable patients there was one partial response for an overall response rate of 3% (95% confidence interval of 0.1–16%). The most common toxicities were nausea, vomiting, and diarrhea. Serious cardiac and pulmonary toxicities were also noted. This drug does not appear to warrant further evaluation in this disease as a single agent.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00872867
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  • 4
    Electronic Resource
    Electronic Resource
    Phase II trial of edatrexate in relapsed or refractory germ cell tumors: A Southwest Oncology Group study (SWOG 9124) (1998)
    Springer
    Investigational new drugs 16 (1998), S. 347-351 
    Details
    ISSN: 1573-0646
    Keywords: germ cell tumors ; edatrexate ; chemotherapy ; salvage
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Up to 30% of patients with advanced germ cell tumors will fail induction chemotherapy or will relapse. New agents with activity in this still potentially curable subgroup of patients are needed. Edatrexate (10-ethyl, 10-deaza-aminopterin) is a methotrexate analogue that has preclinical and clinical activity in breast, lung, and head and neck cancers, as well as in non-Hodgkin's lymphomas. A phase II trial of edatrexate in relapsed or refractory malignant germ cell tumors was conducted by the Southwest Oncology Group (SWOG). Twenty-five patients were enrolled in the trial. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly for four weeks followed by a one-week rest period. The treatment course was repeated every five weeks. Among the 23 patients evaluable for response, there were no objective responses with all patients developing progressive disease. Thirteen patients (56%) developed Grade 3–4 toxicities, predominantly stomatitis and malaise/fatigue/lethargy. One patient developed Grade 4 anemia while another developed grade 4 anemia and thrombocytopenia. No patients discontinued treatment due to toxicity nor were there any toxic deaths. Edatrexate administered in this dose and schedule has no antitumor activity and has substantial toxicity in patients with relapsed or refractory germ cell tumors.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006128024879
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  • 5
    Electronic Resource
    Electronic Resource
    Phase II evaluation of amonafide in renal cell carcinoma (1991)
    Springer
    Investigational new drugs 9 (1991), S. 361-363 
    Details
    ISSN: 1573-0646
    Keywords: renal cell carcinoma ; amonafide
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twenty four patients with advanced renal cell carcinoma were treated in a phase II trial with amonafide 300–450 mg/m2/day on days 1–5 every 21 days. There were no responders, 6 patients had stable disease, 14 experienced progressive disease and 4 were assumed to be non-responders as no evaluation was performed. There were no fatal toxicities although 8 patients had grade 3 or 4 granulocytopenia, 1 patient had grade 4 thrombocytopenia. Other toxicities included grade 3 diarrhea in 1 patient, grade 3 myopathy in 1 patient, severe nausea and vomiting in 1 patient and a facial rash, possibly a hypersensitivity reaction, in 1 patient. The median survival is 7.5 months. At this dosage and schedule, there is no evidence that amonafide has meaningful anti-tumor activity in patients with advanced renal cell carcinoma.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00183582
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  • 6
    Electronic Resource
    Electronic Resource
    Phase II trial of echinomycin for the treatment of advanced renal cell carcinoma (1993)
    Springer
    Investigational new drugs 11 (1993), S. 207-209 
    Details
    ISSN: 1573-0646
    Keywords: echinomycin ; renal cell carcinoma ; kidney
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Forty-nine patients with metastatic or recurrent renal cell carcinoma were treated on a phase II trial of Echinomycin. Treatment consisted of Echinomycin 1.25 mg/m2 intravenously every 28 days. Among the 47 evaluable patients there were no complete responses and only one partial response for an overall response rate of 2% (95% confidence interval, 0–11%). Eighteen patients (38%) experienced toxicity of grade 3 or worse. The most common toxicities were nausea and vomiting. The results of this study indicate that Echinomycin is not sufficiently active to warrant further trials for the treatment of renal cell carcinoma.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874157
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  • 7
    Electronic Resource
    Electronic Resource
    Phase II trial of menogaril in metastatic adenocarcinoma of the prostate (1994)
    Springer
    Investigational new drugs 12 (1994), S. 67-70 
    Details
    ISSN: 1573-0646
    Keywords: prostate cancer ; menogaril ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Menogaril, a semisynthetic anthracycline antibiotic, was administered to patients with metastatic adenocarcinoma of the prostate. Forty-five patients with measurable disease and 45 patients with evaluable disease received 150–200 mg/m2 over 1 hour every 28 days. There were three partial responses (PR) among 87 patients evaluable for response. Myelosuppression was dose limiting. There were two deaths related to leukepenia. Other toxicities included phlebitis, alopecia, nausea and vomiting. One patient developed acute nonlymphocytic leukemia. Menogaril at these doses and schedule is toxic and has no signficant antitumor activity in metastatic adenocarcinoma of the prostate.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873240
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  • 8
    Electronic Resource
    Electronic Resource
    Phase II evaluation of merbarone in renal cell carcinoma (1994)
    Springer
    Investigational new drugs 12 (1994), S. 147-149 
    Details
    ISSN: 1573-0646
    Keywords: merbarone ; renal cell carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The Southwest Oncology Group (SWOG) studied the response rate and toxicity of merbarone (1,000 mg/m2 IV continuous infusion days 1–5, q 21 days) in patients with advanced metastatic renal cell carcinoma. Among 36 eligible patients, there was one partial response for a response rate of 3% (95% C.I. 0.1–15%). There were no mixed responses. There were no treatment related deaths or adverse drug reactions. Significant anemia, diarrhea, and hypercalcemia were observed. Mild to moderate degrees of malaise/fatigue/lethargy, dizziness/vertigo, hyperglycemia, creatinine increase, nausea, vomiting, weight loss, pedal edema, dyspnea, and granulocytopenia were noted. Merbarone does not have significant activity as a single agent in advanced renal cell carcinoma.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874446
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  • 9
    Electronic Resource
    Electronic Resource
    Evaluation of menogaril in renal cell carcinoma (1990)
    Springer
    Investigational new drugs 8 (1990), S. S69 
    Details
    ISSN: 1573-0646
    Keywords: menogaril ; renal cell carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The Southwest Oncology Group (SWOG) studied the response rate and toxicity of menogaril (200 mg/m2 i.v. q 28 days) in patients with advanced metastatic renal cell carcinoma. During the early stage of the trial two partial responses were seen in the first 20 treated patients, and an additional 36 evaluable patients were studied. Three of 56 (5%) evaluable patients achieved partial responses. Significant white cell toxicity was observed. Mild or moderate degrees of thrombocytopenia, gastrointestinal side effects, alopecia and phlebitis occurred. No cardiac toxicity was noted. The low response rate suggests that menogaril in this dose schedule has no role in the treatment of patients with advanced metastatic renal cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00171987
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  • 10
    Electronic Resource
    Electronic Resource
    Phase II evaluation of didemnin B in advanced adenocarcinoma of the kidney (1992)
    Springer
    Investigational new drugs 10 (1992), S. 55-56 
    Details
    ISSN: 1573-0646
    Keywords: didemnin B ; adenocarcinoma of the kidney
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The Southwest Oncology Group studied the response rate and toxicity of didemnin B (3.47 mg/m2 i.v. q 28 days) in patients with advanced renal cell carcinoma. There were no responses in 22 response evaluable patients. Toxicity was significant with 10 patients having grade 3 or 4 toxicity. Toxicity seen included nausea and vomiting, exacerbation of coronary artery disease, hyperglycemia, anorexia, diarrhea and hepatitis. Didemnin B was toxic but inactive in patients with renal cell treated at this dose.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01275484
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