A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma

NCT00483301 | Completed Phase 2 DMC

• 1 other identifier: MEL0205
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.

Conditions

Malignant Melanoma

Keywords

Melanoma; Abraxane; Sorafenib; BAY 43-9006; Abraxis

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma

  one - two years

Secondary Outcomes (1)

• Secondary Objective

  one-two years

Interventions

Sorafenib (BAY 43-9006) DRUG

dosage

ABI-007(Abraxane) DRUG

dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of melanoma with measurable disease
• Patients with stage IV, previously untreated, refractory to initial therapy or progressing after response to initial therapy
• Patients with unresectable stage III, including unresectable in-transit metastases
• Two prior chemotherapy regimen is allowed
• One prior immunotherapy regimen is allowed
• No other concurrent investigational therapy
• Radiation therapy to non-target lesions or to one of multiple target lesions may be allowed on a case-by-case basis
• Patients must be past the nadir from previous cytotoxic therapy
• Age at least 18 years
• ECOG performance status 0-2
• Hemoglobin \> 9.0 g/dl, absolute neutrophil count (ANC) \> 1,500/mm3, platelet count \> 100,000/mm3
• Total bilirubin within normal limits, ALT and AST \< 2.0 x the ULN ( \< 5 x ULN for patients with liver involvement), INR \< 1.5 and aPTT within normal limits. Patients who receive anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care.
• Creatinine \< 1.5 x ULN, serum calcium within normal limits
• Patients with stable brain metastasis who have been treated with either whole brain radiation or Gamma Knife and have been off steroids for \> 4 weeks
• Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least three months after the last administration of protocol drugs. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.

You may not qualify if:

• Cardiac disease: Congestive heart failure \> class II NYHA.
• Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• No known severe hypersensitivity or suspected allergy to sorafenib, ABI-007 or any of the excipients
• Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude progressing brain metastasis.
• Peripheral neuropathy greater than grade II
• Serious intercurrent medical or psychiatric illness, including serious active infection
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding diathesis or coagulopathy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead
• Celgene Corporation: collaborator
• Bayer: collaborator

Study Sites (2)

Dr. Steven O'Day

Los Angeles, California, 90025, United States

Location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Sorafenib; Albumin-Bound Paclitaxel

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)

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; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jose Lutzky, Physician

  Mt. Sinai Medical Center Miami Beach Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 7, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (2)