NCT00281957|CompletedPhase 2Results

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

A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2009-00774S0438CDR0000454925U10CA032102

Study Type

interventional

Target

109

Locations

1 country

Sites

173

Timeline

RegisteredJan 2006

StartedAug 2007

CompletionJan 2011

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

109

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2007

Typical duration for phase_2

Geographic Reach

1 country

173 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

First Submitted

Initial submission to the registry

January 24, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed

1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

July 10, 2012

Completed

Last Updated

May 20, 2014

Status Verified

April 1, 2013

Enrollment Period

3.3 years

First QC Date

January 24, 2006

Results QC Date

June 5, 2012

Last Update Submit

May 2, 2014

Conditions

Recurrent Melanoma Stage IV Melanoma

Outcome Measures

Primary Outcomes (2)

Response Rate (Complete and Partial)
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
Every 8 weeks until progression
4-month Progression-free Survival
Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.
4 months after registration

Secondary Outcomes (2)

One-year Overall Survival
One year after registration
Toxicity
Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).

Study Arms (2)

Arm I (sorafenib, temsirolimus)

EXPERIMENTAL

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

Drug: sorafenib tosylateDrug: temsirolimus

Arm II (sorafenib, tipifarnib)

EXPERIMENTAL

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

Drug: sorafenib tosylateDrug: tipifarnib

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Arm I (sorafenib, temsirolimus)Arm II (sorafenib, tipifarnib)

tipifarnibDRUG

Given orally

Also known as: R115777, Zarnestra

Arm II (sorafenib, tipifarnib)

temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Arm I (sorafenib, temsirolimus)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (173)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants-Fremont

Fremont, California, 94538, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus