Status:
COMPLETED
Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of everolimus when given in combination with gefitinib in patients with progressive glioblastoma multiforme or (progressive castrate metast...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Glioblastoma multiforme (GBM) (phase I only)
- Progressive disease despite standard therapy
- Progressive disease based on 1 of the following:
- New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI
- New or prior lesions that have increased in size by physical examination
- Patients who had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true disease progression (rather than radiation necrosis) by positron-emission tomography scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation
- Castrate metastatic prostate cancer (closed to accrual as of 10/19/2006) (phase I and II)
- Progressive disease despite standard therapy AND castrate levels \< 50 ng/dL of testosterone
- Progressive disease based on 1 or more of the following:
- A minimum of 3 rising levels of prostate-specific antigen (PSA) that are obtained 1 or more weeks apart OR 2 rising PSA values obtained more than 1 month apart with at least a 25% increase over the range of values
- New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI
- New metastatic lesions
- Patients on an antiandrogen as part of initial therapy must show disease progression after discontinuation of the antiandrogen
- Patients who have not undergone surgical orchiectomy must continue with medical therapy (e.g., gonadotropin-releasing hormone analogs) to maintain castrate levels of serum testosterone
- No brain metastases
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- Karnofsky 70-100%
- Life expectancy
- More than 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- WBC ≥ 3,000/mm\^3
- Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine within 1.5 times ULN (\< 1.95 mg/dL at MSKCC)
- Cardiovascular
- No significant cardiovascular disease
- No congestive heart failure
- No New York Heart Association class III or IV cardiac disease
- No active angina pectoris
- No myocardial infarction within the past 6 months
- Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious medical illness
- No severe infection
- No severe malnutrition
- No other active malignancy except non-melanoma skin cancer
- Patients are not considered to have an active malignancy if they have completed prior therapy and currently have a \< 30% risk for relapse
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent biological therapy
- No concurrent immunotherapy
- Chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Prior recent resection of recurrent or progressive GBM allowed provided patient has recovered
- More than 4 weeks since prior major surgery
- Other
- Recovered from all prior therapy
- More than 4 weeks since prior investigational anticancer drugs
- No concurrent anticonvulsant that interacts with CYP3A4 (e.g., phenytoin, carbamazepine, or phenobarbital)
- No other concurrent cytotoxic therapy
- No other concurrent investigational or commercial agents or therapies for the malignancy
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00085566
Start Date
March 1 2004
End Date
February 1 2008
Last Update
January 20 2016
Active Locations (2)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
Vall d'Hebron University Hospital
Barcelona, Spain, 08035