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A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors


- 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.

- Determine the safety and tolerability of this regimen in these patients.

- Determine the relationship between clinical and pharmacokinetic effects of this regimen
in these patients.

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.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 12 weeks


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN


- Creatinine no greater than ULN OR

- Creatinine clearance at least 50 mL/min


- No coronary artery disease

- No symptomatic cardiac dysfunction

- No symptoms suggestive of coronary artery disease with evidence of cardiac pathology


- No symptomatic pulmonary dysfunction


- 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


Biologic therapy

- At least 4 weeks since prior biologic therapy


- 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


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 40% of bone marrow

- No prior mediastinal irradiation


- At least 4 weeks since prior surgery


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Hal W. Hirte, MD, FRCP(C)

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • primary peritoneal cavity cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial