Brief Title
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Official Title
A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the
enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more
tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in
treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or
primary peritoneal cavity cancer.
Detailed Description
OBJECTIVES:
- 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
months.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
7-hydroxystaurosporine
Study Arms / Comparison Groups
UCN-01 in combination with topotecan
Description:
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
Estimated Enrollment
33
Start Date
June 2002
Primary Completion Date
June 2013
Eligibility 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
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 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
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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Hal W. Hirte, MD, FRCP(C), ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00045175
Organization ID
PMH-PHL-005
Secondary IDs
CDR0000256917
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Hal W. Hirte, MD, FRCP(C), Study Chair, Margaret and Charles Juravinski Cancer Centre
Verification Date
June 2016