|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients of all races and ethnic groups are eligible for this trial.
Contacts and Locations| Contact: Marnie Brotherton, RN, OCN, CCRP | 901-259-3233 | mbrotherton@acorncro.com |
Show 89 Study Locations| Study Chair: | Lee Schwartzberg, MD, FACP | Accelerated Community Oncology Research Network |
More Information
| 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 |
|
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 |