Phase 3
Completed N=823
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Mucosal Melanoma · Recurrent Melanoma · Stage IIIA Skin Melanoma · Stage IIIB Skin Melanoma
Source: ClinicalTrials.gov NCT00110019 ↗
Enrolled (actual)
823
Serious AEs
81.4%
Results posted
Sep 2012
Primary outcomePrimary: Overall Survival — 11.1; 11.3 months — p=0.863
Summary
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. 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 tosylate 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 tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
11.1; 11.3 | 0.863 |
| SECONDARY Progression-free Survival |
4.9; 4.2 | 0.092 |
| SECONDARY Objective Response (Complete and Partial Response) Rate |
0.205; 0.182 | 0.427 |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmed melanoma that is metastatic or unresectable; patients must have a history of cutaneous, mucosal or unknown primary site
- Patients who have received prior systemic cytotoxic chemotherapy for treatment of melanoma are ineligible; the following groups are eligible with regard to prior systemic therapy either in the adjuvant or metastatic disease setting:
- No prior therapy
- Immunotherapy consisting of interferon, interleukin-2, granulocyte macrophage colony-stimulating factor (GM-CSF) or vaccine
- One prior investigational therapy (cannot be chemotherapy or an inhibitor of rat sarcoma [Ras], serine/threonine kinase [Raf], or mitogen-activated protein kinase kinase [MEK])
- NOTE: Chemotherapy given via isolated limb perfusion is allowed
- Prior radiation therapy is allowed; however, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
- All sites of disease must be evaluated within 4 weeks of registration; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood count >= 3,000/mm^3
- Absolute granulocyte count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Serum creatinine = = 40 ml/min (neither drug is cleared by the kidney)
- Total bilirubin = = 5 years prior to the time of randomization
- Patients must not have any evidence of bleeding diathesis
- Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's Wort
- Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 4 weeks prior to registration to rule out pregnancy
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well
- Human immunodeficiency virus (HIV)-positive patients are excluded from the study
Data sourced from ClinicalTrials.gov (NCT00110019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.