Status:
COMPLETED
Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop t...
Detailed Description
OBJECTIVES: Primary * Determine the recommended phase II dose of everolimus when administered with low-dose cisplatin in patients with advanced solid tumors. Secondary * Determine the safety and t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Advanced solid tumor (part A)
- Confirmation by core biopsy or fine-needle aspiration allowed
- Solid tumor (part B)
- Recurrent or metastatic disease
- Easily accessible for biopsy
- Measurable disease
- No uncontrolled brain or leptomeningeal metastases
- No requirement for glucocorticoids
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin \> 10 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present)
- Creatinine normal OR creatinine clearance ≥ 55 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
- No HIV positivity
- No peripheral neuropathy ≥ grade 2
- No hypertriglyceridemia ≥ grade 2
- No impaired gastrointestinal function or gastrointestinal disease that may alter the absorption of everolimus, including any of the following:
- Ulcerative disease
- Uncontrolled nausea
- Vomiting
- Diarrhea
- Malabsorption syndrome
- Small bowel resection
- No other concurrent severe and/or uncontrolled medical disease that would compromise study participation, including any of the following:
- Uncontrolled diabetes
- Unstable angina
- New York Heart Association class III or IV congestive heart failure
- PRIOR CONCURRENT THERAPY:
- No more than 3 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease
- At least 4 weeks since prior major surgery and recovered
- At least 4 weeks since prior radiation therapy and recovered
- At least 4 weeks since prior systemic anticancer therapy and recovered
- At least 4 weeks since prior and no other concurrent investigational drugs
- No prior everolimus or other agents specifically targeting mTOR
- No prior radiation therapy to \> 25% of the bone marrow
- No prior radiation therapy to the whole pelvis and/or brain
- No concurrent chronic steroid treatment (\> 5 mg/day of prednisone)
- Concurrent low-dose steroid replacement regimens (≤ 5 mg/day of prednisone) allowed
- No concurrent immunosuppressive agents
- No other concurrent anticancer agents
- No concurrent agents known to be strong inhibitors or inducers of isoenzyme CYP3A
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00423865
Start Date
November 1 2006
End Date
September 1 2011
Last Update
May 25 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065