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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00072267
Enrollment
Unknown
Registered
2003-11-06
Start date
2004-01-31
Completion date
Unknown
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III ovarian epithelial cancer

Brief summary

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

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.

Interventions

DRUGtopotecan hydrochloride

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University Health Network, Toronto
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026