UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed Description
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OBJECTIVES: Primary Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer. Secondary Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients. Determine the progression-free, median, and overall survival of patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients. OUTLINE: This is a 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 up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Official Title
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A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: 7-hydroxystaurosporine
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Progressive, persistent, or recurrent disease Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy Tumor lesions accessible for biopsy Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator No more than 2 prior chemotherapy regimens At least 1 regimen must have contained a platinum agent (i.e., 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 history of coronary artery disease No symptomatic cardiac dysfunction No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary No symptomatic pulmonary dysfunction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 8 weeks after study participation No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents No insulin-dependent diabetes mellitus Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy and recovered Chemotherapy See Disease Characterisitcs More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior topotecan No other prior topoisomerase I inhibitors Endocrine therapy More than 4 weeks since prior hormonal therapy and recovered Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 40% of bone marrow No prior mediastinal irradiation Surgery More than 4 weeks since prior surgery and recovered Other No other concurrent anticancer therapy No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 7-hydroxystaurosporine|nan|
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III ovarian epithelial cancer