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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hal W. Hirte, MD, FRCP(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre

Authority:

United States: Federal Government

Study ID:

CDR0000339563

NCT ID:

NCT00072267

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • stage III ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

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