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A Double-blind, Randomized, Placebo-controlled Phase III Trial of Carboplatin, Paclitaxel, and BAY 43-9006 Versus Carboplatin, Paclitaxel, and Placebo in Patients With Unresectable Stage III or IV Mel

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Trial Conditions
  • Melanoma (Skin)
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib is more effective than carboplatin and paclitaxel in treating melanoma. PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and sorafenib to see how well they work compared to carboplatin and paclitaxel in treating patients with unresectable stage III or stage IV melanoma.

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Inclusion criteria:

- Histologically or cytologically confirmed melanoma meeting 1 of the following stage

- Unresectable stage III disease

- Stage IV disease

- Must have 1 of the following melanoma types:

- Cutaneous

- Mucosal

- Unknown primary site

- Measurable disease

- Prior radiotherapy to a measurable lesion allowed provided there is radiographic
evidence of disease progression of that lesion

- 18 and over

- ECOG Performance status 0-1

- Negative pregnancy test

- Fertile patients must use effective contraception

- White Blood Cell (WBC) count ≥ 3,000/mm^3

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (< 3.0 times ULN if Gilbert's
disease is present)

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (≤ 5.0
times ULN if liver metastases are present)

- Prothrombin time (INR) ≤ 1.5

- Partial thromboplastin time (PTT) normal

- Creatinine ≤ 2.0 times ULN OR Creatinine clearance ≥ 40 mL/min

- Prior interferon, interleukin-2, sargramostim (GM-CSF), or vaccine allowed in the
adjuvant or metastatic setting

- At least 4 weeks since prior immunotherapy and recovered

- Chemotherapy given via isolated limb perfusion is allowed

- At least 4 weeks since prior radiotherapy and recovered

- At least 4 weeks since prior and no other concurrent investigational agents

Exclusion criteria:

- Ocular melanoma

- History or clinical evidence of brain metastasis by brain MRI

- Uncontrolled hypertension

- Myocardial infarction

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease > grade 2 within the past year

- Other clinically significant cardiovascular disease

- Pregnant or nursing

- HIV positivity

- Other malignancy within the past 5 years except basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of

- Ongoing or active infection requiring parenteral antibiotics

- Other serious illness

- Psychiatric illness or social situation that would preclude study compliance

- Prior systemic cytotoxic chemotherapy for the treatment of melanoma in the adjuvant
or metastatic setting

- More than 1 prior investigational therapy in the adjuvant or metastatic setting

- Prior investigational therapy comprising inhibitors of Ras, Raf, or MEK

- Concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
carbamazepine, or phenobarbital)

- Concurrent rifampin

- Concurrent Hypericum perforatum (St. John's wort)

- Evidence of bleeding diathesis

Gender: Both
Steward Physician(s)
  • Keith T. Flaherty, MD
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
  • carboplatin
  • paclitaxel
  • sorafenib tosylate
  • placebo
Physician Researcher

Investigator Name:

  • Keith T. Flaherty, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00110019
Volunteers:  Not Accepting Healthy Volunteers

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