Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

NCT01851408 | Withdrawn Phase 2

• 4 other identifiers: CDR00004801572005-0215N01CM62202NCI-2009-00131
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.

Conditions

Melanoma; Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma

Keywords

Sorafenib; Temsirolimus; Stage IV; recurrent; unresectable; non-choroidal origin; CCI-779; BAY43-9006; metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006

  Up to 5 years

Secondary Outcomes (3)

• Progression-free survival

  The duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress, assessed up to 5 years

• Overall survival

  5 years

• Noncompartmental pharmacokinetic parameters of BAY43-9006 and CCI-779 estimated using a validated commercial software

  Week 1 and 3

Study Arms (1)

Temsirolimus + Sorafenib

EXPERIMENTAL

Temsirolimus intravenous (IV) over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.

Drug: sorafenib tosylate; Drug: temsirolimus

Interventions

sorafenib tosylate DRUG

Given orally

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

Temsirolimus + Sorafenib

temsirolimus DRUG

Given IV

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

Temsirolimus + Sorafenib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed melanoma, meeting 1 of the following criteria: recurrent or unresectable stage III disease, stage IV disease, non-choroidal origin.
• Tumor must be accessible to biopsy unless appropriate tumor sample collection has occurred within the past 3 months and patient agrees to provide these samples for this study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Bilirubin normal
• Creatinine normal or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study treatment.
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib or temsirolimus.
• No uncontrolled hypertension, defined as systolic blood pressure \> 140 mm Hg on 2 separate days \< 1 week prior to study entry OR diastolic pressure \> 90 mm Hg on 2 separate days \< 1 week prior to study entry.
• No evidence of bleeding diathesis or coagulopathy.
• No condition that would impair the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; or active peptic ulcer disease).
• No uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness or social situations that would limit study compliance.
• No traumatic injury within the past 3 weeks.
• No more than 1 prior systemic chemotherapy regimen for metastatic melanoma (Phase II).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• M.D. Anderson Cancer Center: collaborator

Related Links

• University of Texas MD Anderson Cancer Center official website

MeSH Terms

Conditions

Melanoma; Recurrence

Interventions

Sorafenib; temsirolimus; Sirolimus

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Macrolides; Lactones

Study Officials

• Kevin Kim

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 10, 2013
• Study Start: April 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 15, 2015

Record last verified: 2013-05