Status:
COMPLETED
Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ovarian Sarcoma
Ovarian Stromal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of temsirolimus, carboplatin, and paclitaxel in treating patients with advanced solid tumors. Temsirolimus may stop the growth of tumor ce...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and recommended phase II dose of temsirolimus, carboplatin, and paclitaxel in patients with advanced solid tumors. SECONDARY OBJECTI...
Eligibility Criteria
Inclusion
- Criteria:
- Histologically confirmed solid tumors
- Measurable or nonmeasurable disease: No serum tumor marker elevation as the only evidence of disease; Patients with ovarian or endometrial cancer must have measurable disease, defined as \>= 1 lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- Advanced disease; Refractory to standard therapy OR no standard therapy is available
- Carboplatin and paclitaxel considered reasonable therapeutic option
- No known brain metastases
- ECOG performance status 0-1
- Life expectancy \>= 12 weeks
- Absolute granulocyte count \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Bilirubin =\< 1.5 times upper limit of normal (ULN)
- AST and ALT =\< 3 times ULN (5 times ULN if documented liver metastases)
- Fasting serum cholesterol =\< 9.0 mmol/L
- Fasting triglycerides =\< 4.56 mmol/L
- Creatinine normal OR creatinine clearance \>= 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Accessible for treatment and follow up
- No serious cardiovascular illness, including any of the following:
- myocardial infarction within the past 6 months, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, cardiac arrhythmia, uncontrolled hypertension
- No preexisting sensory or motor neuropathy \>= grade 2 due to previous chemotherapy; Local or regional neurological findings related to previous injury or disease allowed
- No hearing loss \>= grade 2 from any cause
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus
- No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following: History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit study compliance, Active uncontrolled infection or nonhealing wounds, OR;
- At least 4 weeks since prior radiotherapy (except low-dose, palliative radiotherapy) and recovered
- At least 4 weeks since prior chemotherapy and recovered
- No more than 2 prior chemotherapy regimens
- Prior therapy with carboplatin and/or paclitaxel allowed provided the patient has no persistent related toxicity \>= grade 1 AND retreatment with the combination is clinically indicated (e.g., second-line therapy for ovarian cancer with \> 6-month treatment-free interval)
- At least 21 days since prior major surgery and recovered
- No prior mTOR inhibitor
- No concurrent prophylactic hematopoietic colony-stimulating factors
- No other concurrent anticancer therapy or investigational agents
- Active peptic ulcer disease, Any other medical condition that might be aggravated by treatment
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00408655
Start Date
February 1 2007
Last Update
June 19 2014
Active Locations (1)
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1
National Cancer Institute of Canada Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6