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UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Clinical research trials and UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer. UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer clinical trial. Human subjects often get the best healthcare possible for their UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer  UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
For Condition: recurrent ovarian epithelial cancer,Fallopian Tube Cancer,peritoneal cavity cancer
Status: Completed
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrentovarian epithelial cancer, fallopian tube cancer, or primaryperitoneal cavity cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. - Determine the safety and tolerability of this regimen in these patients. - Determine the relationship between clinical and pharmacokinetic effects of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional ovarian epithelial cancer patients are then treated at the recommended phase II dose. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer - Measurable disease outside of field of prior radiotherapy OR - Progressive disease within field after radiotherapy - Must have had no more than 2 prior chemotherapy regimens - At least 1 prior regimen must have included a platinum agent (e.g., carboplatin or cisplatin) - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN Renal - Creatinine no greater than ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No coronary artery disease - No symptomatic cardiac dysfunction - No symptoms suggestive of coronary artery disease with evidence of cardiac pathology Pulmonary - No symptomatic pulmonary dysfunction Other - No prior allergic reaction attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in this study - No insulin-dependent diabetes mellitus - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior biologic therapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No prior topotecan (other prior topoisomerase I inhibitors allowed) Endocrine therapy - At least 4 weeks since prior hormonal therapy Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No prior radiotherapy to more than 40% of bone marrow - No prior mediastinal irradiation Surgery - At least 4 weeks since prior surgery Other - Recovered from all prior therapy - No other concurrent investigational agents - No other concurrent anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HalHirte, Study Chair, Margaret and Charles Juravinski Cancer Centre
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Additional Information:
Study ID Numbers: CDR0000256917; NCI-5518,PMH-PHL-005
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045175
Other Fallopian Tube Cancer Studies:
1. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
2. TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
3. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
4. Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Related Studies:
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UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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