Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC - Full Text View

Sponsor:	Accelerated Community Oncology Research Network
Information provided by (Responsible Party):	Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:	NCT00828841

Purpose

This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Cetuximab Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine Drug: Cisplatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride Cetuximab

U.S. FDA Resources

Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:

To evaluate overall survival with three different regimens of chemotherapy and cetuximab [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate safety and 1-year survival with three different regimens of chemotherapy and cetuximab [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate overall survival by histology (squamous cell vs. non-squamous cell) across treatment arms (pooled analysis) [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Paclitaxel, Carboplatin and Cetuximab Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.	Drug: Cetuximab Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks. Other Name: Erbitux Drug: Paclitaxel Paclitaxel 200 mg/m2 Day 1 every 21 days Other Name: Taxol Drug: Carboplatin Carboplatin AUC 6 Day 1 every 21 days Other Name: Paraplatin
Active Comparator: Platinum, Gemcitabine, and Cetuximab Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.	Drug: Cetuximab Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks. Other Name: Erbitux Drug: Carboplatin Carboplatin AUC 6 Day 1 every 21 days Other Name: Paraplatin Drug: Gemcitabine Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Other Name: Gemzar Drug: Cisplatin Cisplatin 75 mg/m2 Day I every 21 days Other Name: Platinol
Active Comparator: Platinum, Pemetrexed, and Cetuximab Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.	Drug: Cetuximab Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks. Other Name: Erbitux Drug: Carboplatin Carboplatin AUC 6 Day 1 every 21 days Other Name: Paraplatin Drug: Cisplatin Cisplatin 75 mg/m2 Day I every 21 days Other Name: Platinol

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent before study-related activities
Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent NSCLC after resection or radiation for earlier stage disease
Measurable or evaluable disease (per modified RECIST)
Male or female ≥ 18 years of age
ECOG performance status of 0-1
White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
Total bilirubin ≤ 1.5 x ULN
AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
Serum creatinine ≤ 1.25 x ULN
Recovery from prior surgery or radiation to Grade 1 or better toxicity
Women of childbearing potential and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
Women who are pregnant or breastfeeding
Women with a positive pregnancy test during screening or prior to study drug administration
Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
Previous exposure to EGFR-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization
Treatment with any investigational agent(s) within 4 wks prior to study entry
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
Carcinoid, atypical carcinoid or small cell lung cancer
Symptomatic or uncontrolled mets in the central nervous system
Prior invasive malignancy requiring ongoing therapy within the past year
Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV
MI within 6 months prior to study entry, uncontrolled CHF; or any current Grade 3 or 4 cardiovascular disorder despite treatment
Known allergic/hypersensitivity reaction to any of the components of study treatments
Peripheral neuropathy ≥ Grade 2, as assessed by NCI-CTC Version 3.0
History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828841

Show 84 Study Locations

Sponsors and Collaborators

Accelerated Community Oncology Research Network

Investigators

Study Chair:

Lee Schwartzberg, MD, FACP

Accelerated Community Oncology Research Network

More Information

No publications provided

Responsible Party:	Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:	NCT00828841 History of Changes
Other Study ID Numbers:	AC01L08
Study First Received:	January 23, 2009
Last Updated:	January 18, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cetuximab
Cisplatin
Carboplatin
Paclitaxel

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on February 09, 2012