Recruiting
Phase 2

Sorafenib, Tamoxifen, Cisplatin

Sponsor:

San Diego Pacific Oncology & Hematology Associates

Code:

NCT00492505

Conditions

Melanoma (Skin)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cisplatin

sorafenib tosylate

tamoxifen citrate

adjuvant therapy

Study Details

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)

Study ID

NCT00492505

Start date

Apr, 2007

Status verified date

Jul, 2009

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

cisplatin

sorafenib tosylate

tamoxifen citrate

adjuvant therapy

Primary outcome measure

  • Relapse-free survival [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]
  • Toxicity [ Time Frame: undefined ]

Central Contacts and Locations

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Edward F. McClay, MD

760-452-3340emcclay@pacificoncology.com

More Information

Sponsor

San Diego Pacific Oncology & Hematology Associates

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

Keywords

  • stage IIIA melanoma
  • stage IIIB melanoma
  • stage IIIC melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego Pacific Oncology & Hematology Associates on 2014-01-10.