Status:
UNKNOWN
Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide...
Detailed Description
OBJECTIVES: Primary * Determine the safety profile and the maximum tolerated dose of sorafenib tosylate and temozolomide in patients with stage III-IV melanoma. (Phase I) * Evaluate progression-free...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of unresectable or metastatic melanoma
- Stage III or IV disease
- Previously treated or untreated metastatic disease
- At least one unidimensionally measurable lesion by RECIST criteria by scan or MRI
- No concurrent brain or CNS metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin \> 9 g/dL
- PT, INR, and PTT \< 1.5 times upper limit of normal (ULN)
- Transaminases \< 2.5 times ULN (\< 5 in the case of liver metastases)
- Amylase and lipase \< 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Serum creatinine \< 1.5 times ULN
- Normal respiratory, cardiac, and neurological function
- Not pregnant or nursing
- No history of any of the following cardiac conditions:
- NYHA class II-IV heart failure
- Coronary disease
- Myocardial infarction within the past 6 months
- Cardiac arrhythmia requiring treatment with something other than beta-blockers or digoxin
- Severe uncontrolled hypertension
- No severe active infection \> grade 2
- No epilepsy requiring medical treatment
- No other cancer except for carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumors, or curatively treated cancer \> 3 years ago
- No HIV or hepatitis B or C positivity
- No lactase or galactokinase deficiency, galactose intolerance, or disease accompanied by malabsorption of glucose or galactose
- No allergy to the study drugs or to dacarbazine
- Able to swallow medications
- No patients deprived of liberty
- No psychological, familial, social, or geographic conditions that would preclude clinical follow up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior organ transplantation
- No prior temozolomide or sorafenib tosylate
- More than 30 days since other prior antitumor chemotherapy, immunotherapy, hormonal therapy, or investigational agent
- More than 30 days since prior study drugs
- More than 3 weeks since prior radiotherapy
- More than 3 weeks since prior biological response modifiers (i.e., filgrastim \[G-CSF\])
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00811759
Start Date
June 1 2007
Last Update
October 7 2010
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, F-94805