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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with chemotherapy may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Everolimus; Paclitaxel; Sirolimus

Criteria

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