Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

NCT00998101 | Withdrawn Phase 2 DMC

• 3 other identifiers: LCCC 0816P30CA016086CDR0000656960
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth. PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone

  Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.

  42 days

Secondary Outcomes (3)

• Progression-free survival

  2 years

• Overall survival

  4 years

• Number of subjects experiencing adverse events

  1 year

Interventions

cetuximab DRUG

400 mg/m2 Cycle 1 day 1 only over 120 minutes 250 mg/m2 Cycle 1 days 8,15 AND on all other cycles days 1,8,15 over 60 minutes

Also known as: Erbitux

carboplatin DRUG

AUC=6 Day 1 of treatment over 30 minutes every 21 days

ixabepilone DRUG

30 mg/m2 , Day 1 over 3 hours every 21 days

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Chemotherapy-naive * Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy * Stage IV disease * Must have pathology block or unstained slides from initial or subsequent diagnosis * Diagnosis made via a core biopsy (not a fine-needle aspirate) required * Measurable disease as defined by RECIST guidelines * For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field * Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician * No IgE cetuximab antibody PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Creatinine \< 2.0 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis) * Bilirubin ≤ 1.5 times ULN * Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0 * No prior severe allergic reaction to any of the following: * Carboplatin * Taxane therapy * Monoclonal antibody * Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil) * No active or uncontrolled infection * No significant history of uncontrolled cardiac disease including, but not limited to, any of the following: * Uncontrolled hypertension * Unstable angina * Myocardial infarction within the past 6 months * Uncontrolled congestive heart failure * Cardiomyopathy with decreased ejection fraction * No underlying interstitial lung disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 1 week since prior and no concurrent therapeutic radiotherapy * Palliative radiotherapy for painful bone lesions allowed * At least 6 months since prior adjuvant chemotherapy * No investigational agent(s) within the past 30 days * Not requiring concurrent treatment with any of the following: * Ketoconazole * Itraconazole * Ritonavir * Amprenavir * Indinavir * Nelfinavir * Delavirdine * Voriconazole * No other concurrent chemotherapy or cetuximab

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Carboplatin; ixabepilone

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Thomas E. Stinchcombe, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2009
• First Posted: October 20, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 6, 2012

Record last verified: 2012-03