Status:
COMPLETED
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Steven Waggoner, MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase ...
Detailed Description
OBJECTIVES: Primary * To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies. * To determine the safety and tolerability...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically\* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available
- All tumor types allowed NOTE: \*Histologic confirmation of recurrence is not required
- Measurable or nonmeasurable disease
- If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan
- No "borderline tumors" or tumors with low malignant potential
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
- AST/ALT ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support)
- No severe gastrointestinal bleeding or intestinal obstruction
- No other condition that would affect gastrointestinal absorption and motility
- No septicemia, severe infection, or acute hepatitis
- No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer
- No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy
- PRIOR CONCURRENT THERAPY:
- At least 28 days since prior investigational drugs (including cytotoxic drugs)
- At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered
- No more than 3 prior chemotherapy regimens
- No prior topotecan hydrochloride or other camptothecin analogs
- No prior radiotherapy to \> 25% of the bone marrow
- No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer
- No concurrent administration of any of the following:
- P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers
- Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers
- No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers
- Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00842452
Start Date
February 1 2009
End Date
April 1 2011
Last Update
April 5 2013
Active Locations (1)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106