Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma

NCT00811759 | Unknown Phase 1

• 7 other identifiers: CDR0000626803IGR-CSET-2006/1261IGR-SORAF-TEM ST1INCA-RECF0818EUDRACT-2007-00527-18SCHER-IGR-CSET-2006/1261BAYER-IGR-CSET-2006/1261
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; stage III melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (Phase I)

• Progression-free survival at 12 weeks (Phase II)

Interventions

sorafenib tosylate DRUG

temozolomide DRUG

gene expression analysis GENETIC

mutation analysis GENETIC

laboratory biomarker analysis OTHER

pharmacological study OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[G-CSF\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Melanoma

Interventions

Sorafenib; Temozolomide; Gene Expression Profiling; Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dacarbazine; Triazenes; Imidazoles; Azoles; Genetic Techniques; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Caroline Robert, MD

  Gustave Roussy, Cancer Campus, Grand Paris

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2009
• Last Updated: October 7, 2010

Record last verified: 2009-07

Locations

FR (1)