Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors

This is an interventional treatment trial for Ovarian Sarcoma Read More

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