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Sorafenib With Either Temsiro...

Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

NCT ID: NCT00281957

Last Updated: 2014-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-01-31

Brief Summary

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This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Conditions

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Recurrent Melanoma Stage IV Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (sorafenib, temsirolimus)

Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

Group Type EXPERIMENTAL

sorafenib tosylate

Intervention Type DRUG

Given orally

temsirolimus

Intervention Type DRUG

Given IV

Arm II (sorafenib, tipifarnib)

Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21

Group Type EXPERIMENTAL

sorafenib tosylate

Intervention Type DRUG

Given orally

tipifarnib

Intervention Type DRUG

Given orally

Interventions

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sorafenib tosylate

Given orally

Intervention Type DRUG

tipifarnib

Given orally

Intervention Type DRUG

temsirolimus

Given IV

Intervention Type DRUG

Other Intervention Names

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BAY 43-9006 BAY 43-9006 Tosylate Salt BAY 54-9085 Nexavar SFN R115777 Zarnestra CCI-779 cell cycle inhibitor 779 Torisel

Eligibility Criteria

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Inclusion Criteria

Criteria:

* Histologically confirmed malignant melanoma of cutaneous origin
* Patients with unknown primary allowed
* Stage IV disease
* Measurable disease by physical examination, CT scan, MRI or plain x-ray
* Unresectable disease
* Residual or recurrent disease after prior surgery for stage IV disease allowed
* Residual tumor at the site of incomplete resection may be included only as nonmeasurable disease
* Must have serum lactate dehydrogenase (LDH) levels measured
* Must have tissue specimens available
* Negative brain CT scan or MRI within the past 42 days
* Creatinine =\< 1.5 times ULN
* Absolute neutrophil count \>= 1,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Fasting cholesterol =\< 350 mg/dL (lipid-lowering agents allowed)
* Triglycerides =\< 300 mg/dL (lipid-lowering agents allowed)
* No symptomatic sensory neuropathy \>= grade 2
* No evidence of bleeding diathesis or coagulopathy
* No congestive heart failure
* No myocardial infarction within the past 2 months
* No New York Heart Association class III or IV heart disease
* No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease)
* No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or econazole)
* No history of allergic reaction to compounds of similar chemical or biologic composition as tipifarnib
* No hypertension with systolic blood pressure (BP) \> 140 mm Hg or diastolic BP \> 90 mm Hg
* Patients with well-controlled hypertension allowed
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled diabetes
* No uncontrolled diabetes
* No active uncontrolled infection
* No other severe or uncontrolled medical disease
* No psychologic or medical condition that would preclude study treatment or compliance
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer that is in complete remission, or carcinoma in situ of the cervix
* At least 90 days since prior adjuvant therapy, including cytotoxic agents
* At least 28 days since prior radiotherapy
* At least 28 days since prior surgery to remove the tumor
* No prior systemic therapy for stage IV melanoma
* No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway, or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs such as sorafenib, temsirolimus, or tipifarnib
* Concurrent lipid-lowering agents allowed
* Not requiring full-dose anticoagulation for recent thrombotic event
* No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients
* No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital; rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole; ritonavir; cyclosporine; phenytoin; grapefruit juice
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* SGOT or SGPT =\< 2.5 times ULN (5 times ULN if hepatic metastases)
* No history of brain metastases
* Zubrod performance status 0-1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Margolin

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Site Status

University of Southern California/Norris Cancer Center

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

El Camino Hospital

Mountain View, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Breast Surgeons Inc

Oakland, California, United States

Site Status

Bay Area Tumor Institute CCOP

Oakland, California, United States

Site Status

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Site Status

Tom K Lee Inc

Oakland, California, United States

Site Status

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Site Status

Valley Medical Oncology Consultants

Pleasanton, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Sutter General Hospital

Sacramento, California, United States

Site Status

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Cancer Centers of Central Florida PA

Leesburg, Florida, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

South Georgia Medical Center

Valdosta, Georgia, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Genesis Medical Center - East Campus

Davenport, Iowa, United States

Site Status