Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI PMH-PHL-019 NCI-6402, NCT00072267, 6402

Objectives

Primary

1. 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

1. Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
2. Determine the progression-free, median, and overall survival of patients treated with this regimen.
3. Determine the safety and tolerability of this regimen in these patients.
4. Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.

Entry 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

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 19-33 patients will be accrued for this study within 5-11 months.

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.

Trial Contact Information

Trial Lead Organizations

Princess Margaret Hospital

Hal Hirte, MD, FRCP(C), Principal investigator		Ph: 905-387-9495 ext. 6460 Email: Hal.Hirte@jcc.hhsc.ca

Registry Information
Official Title		A Phase II Study of UCN-01 in Combination with Topotecan in Patients with Advanced Ovarian Cancer
Trial Start Date		2004-01-14
Registered in ClinicalTrials.gov		NCT00072267
Date Submitted to PDQ		2003-09-29
Information Last Verified		2005-02-10
NCI Grant/Contract Number		CM17107

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