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

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 2


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: 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:

Overall Survival by Treatment Arm [ Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1-year Survival by Treatment Arm [ Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact. ] [ Designated as safety issue: No ]
Overall Survival by Histology [ Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact. ] [ Designated as safety issue: No ]


Enrollment:	601
Study Start Date:	December 2008
Study Completion Date:	August 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Paclitaxel, Carboplatin, Cetuximab (Arm A) 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.	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, Cetuximab (Arm B) 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, Cetuximab (Arm C) 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. The choice of platinum-based chemotherapy is also 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 non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease
Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)
Male or female ≥ 18 years of age
Eastern Cooperative Oncology Group (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 upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (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 (WOCBP) 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 epidermal growth factor receptor (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 weeks 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
Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; 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 Common Terminology Criteria for Adverse Events, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received:	August 7, 2013
Last Updated:	October 11, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin Cetuximab Cisplatin Gemcitabine Paclitaxel	Anti-Infective Agents Antimetabolites Antimetabolites, Antineoplastic Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 26, 2015