Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving paclitaxel together with carboplatin is more effective than giving temozolomide alone in treating patients with melanoma.

PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with carboplatin or giving temozolomide alone works in treating patients with stage IV melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Dacarbazine; Paclitaxel; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic melanoma

• Stage IV disease

• Progressive disease

• No known standard therapy that is potentially curative or proven capable of extending life expectancy exists

• Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease

• Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• ANC ≥ 1,500/mL

• Platelet count ≥ 100,000/mL

• Hemoglobin ≥ 9 g/dL

• Creatinine ≤ 2.5 x upper limit of normal (ULN)

• AST ≤ 3 x ULN

• Alkaline phosphatase ≤ 3.0 x ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after completion of study therapy

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Active infection

• NYHA class III or IV congestive heart failure

• No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix

• Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• At least 4 weeks since prior radiotherapy

• At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)

• No prior chemotherapy treatment with agents similar to study drugs

• No prior chemotherapy in the metastatic setting (for chemo-naive patients)

• No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used

• No other concurrent investigational agents

• No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy