Brief Title
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian 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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
7-hydroxystaurosporine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
January 2004
Primary Completion Date
April 2005
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hal W. Hirte, MD, FRCP(C), ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00072267
Organization ID
PMH-PHL-019
Secondary IDs
CDR0000339563
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Hal W. Hirte, MD, FRCP(C), Principal Investigator, Margaret and Charles Juravinski Cancer Centre
Verification Date
July 2015