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Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC
This study is currently recruiting participants.
Verified by Accelerated Community Oncology Research Network, November 2009
First Received: January 23, 2009   Last Updated: November 12, 2009   History of Changes
Sponsor: Accelerated Community Oncology Research Network
Collaborators: ImClone LLC
Advanced Clinical Trial Solutions, LLC
Information provided by: 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: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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:


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
Paclitaxel, Carboplatin and Cetuximab: Active Comparator
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.
Drug: Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Platinum, Gemcitabine, and Cetuximab: Active Comparator
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.
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Drug: Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Platinum, Pemetrexed, and Cetuximab: Active Comparator
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.
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days

  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

Contacts
Contact: Marnie Brotherton, RN, OCN, CCRP 901-259-3233 mbrotherton@acorncro.com

  Show 89 Study Locations
Sponsors and Collaborators
Accelerated Community Oncology Research Network
ImClone LLC
Advanced Clinical Trial Solutions, LLC
Investigators
Study Chair: Lee Schwartzberg, MD, FACP Accelerated Community Oncology Research Network
  More Information

No publications provided

Responsible Party: Accelerated Community Oncology Research Network, Inc. (ACORN) ( Marnie Brotherton, RN, OCN, CCRP (Sr. Project Manager) )
Study ID Numbers: AC01L08
Study First Received: January 23, 2009
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00828841     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Cetuximab
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2009