Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

NCT00492505 | Unknown Phase 2

• 2 other identifiers: CDR0000551556POHA-0602
• Study Type: interventional
• Target: 200
• 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 tamoxifen and cisplatin, 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 tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib together with tamoxifen and cisplatin works in treating patients with high-risk stage III melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma

Outcome Measures

Primary Outcomes (3)

• Relapse-free survival

• Overall survival

• Toxicity

Interventions

cisplatin DRUG

sorafenib tosylate DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Confirmed diagnosis of melanoma * High-risk, stage III disease * No measurable metastatic disease * Has undergone surgery within the past 8 weeks * Surgically rendered disease free PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL * Liver function tests ≤ 3 times the upper limit of normal * ANC ≥ 1,200/mm³ * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No myocardial infarction within the past 6 months * No congestive heart failure requiring medication * No pulmonary disease requiring supplemental oxygen * No dyspnea at rest * No active infection * No chronic underlying immunodeficiency disease * No other serious illness that, in the physicians' opinion, may compromise the safety of the patient * No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer * No thromboembolic disease within the past 6 months PRIOR CONCURRENT THERAPY: * No prior tamoxifen citrate, sorafenib tosylate, or cisplatin * No concurrent radiotherapy or surgery

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

Sponsors & Collaborators

• San Diego Pacific Oncology & Hematology Associates: lead

Study Sites (1)

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, 92024, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Cisplatin; Sorafenib; Tamoxifen; Chemotherapy, Adjuvant

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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; Stilbenes; Benzylidene Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Edward F. McClay, MD

  San Diego Pacific Oncology & Hematology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2011
• Last Updated: January 10, 2014

Record last verified: 2009-07

Locations

US (1)