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 Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI PMH-PHL-005 NCI-5518, NCT00045175, 5518

Objectives

1. 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.
2. Determine the safety and tolerability of this regimen in these patients.
3. Determine the relationship between clinical and pharmacokinetic effects of this regimen in these patients.

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

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

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 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

Expected Enrollment

A total of 3-30 patients will be accrued for this study within 6-10 months.

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.

Trial Contact Information

Trial Lead Organizations

Princess Margaret Hospital

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

Registry Information
Official Title		A Phase I Study of UCN-01 in Combination with Topotecan in Patients with Solid Tumors
Trial Start Date		2002-06-13
Registered in ClinicalTrials.gov		NCT00045175
Date Submitted to PDQ		2002-06-28
Information Last Verified		2004-04-27
NCI Grant/Contract Number		CM17107

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