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Home > "B" Clinical Trials Conditions > Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer  Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
For Condition: stage 4 ovarian epithelial cancer,stage 1 ovarian epithelial cancer,recurrent ovarian epithelial cancer,stage 2 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Completed
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer. II. Determine the response rate in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment. Patients are followed for at least 4 weeks after treatment, then every 3 months. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven ovarian epithelial cancer - Progressive disease during or after completion of at least one platinum based chemotherapy regimen Bidimensionally measurable disease - At least 2 cm by x-ray, CT scan, or ultrasound No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth) --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered - No more than 2 prior multidrug chemotherapy regimens - No more than 1 prior single agent chemotherapy regimen Endocrine therapy: - At least 4 weeks since prior endocrine therapy and recovered - No concurrent steroids - Concurrent hormone replacement therapy allowed Radiotherapy: - At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered - No concurrent radiotherapy Surgery: At least 4 weeks since prior major thoracic or abdominal surgery Other: No other concurrent anticancer therapy or investigational drugs --Patient Characteristics-- Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: - Hemoglobin at least 10 g/dL - WBC at least 4,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.7 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Other: - No active, uncontrolled infection - No nonmalignant systemic disease which would increase risk to patient - No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GordonJayson, Study Chair, Cancer Research Campaign Clinical Trials Centre
Royal Infirmary
Glasgow, Scotland, G4 0SF
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067219; CRC-PHASE-II-PH2/039,NCI-T99-0027
Study Start Date: July 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004008
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. National Ovarian Cancer Early Detection Program Screening and Genetic Study
2. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
4. Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
5. Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
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