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A Study to Test IMC-A12 With and Without Other Standard Chemotherapies in Patients With Lung Cancer Who Have Not Received Chemotherapy Before
This study is currently recruiting participants.
Verified by ImClone LLC, August 2009
First Received: March 26, 2009   Last Updated: August 20, 2009   History of Changes
Sponsored by: ImClone LLC
Information provided by: ImClone LLC
ClinicalTrials.gov Identifier: NCT00870870
  Purpose

The purpose of this study is to determine the number of patients whose cancer shrinks or disappears after treatment on the study.


Condition Intervention Phase
Non-small Cell Lung Cancer
Biological: Cetuximab
Drug: Gemcitabine
Drug: Carboplatin
Biological: IMC-A12
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Time To Progression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety Profile of IMC-A12 in Combination with Cetuximab, Carboplatin and Gemcitabine [ Time Frame: 6 weeks; AE monitoring will occur on continuous basis for the duration of patients on study therapy ] [ Designated as safety issue: Yes ]
  • Evaluate the Pharmacokinetics of IMC-A12 (GCC + A12 arm only) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine, Carboplatin, Cetuximab + A12: Experimental

Patients in this arm will receive the following treatment schedule for the first 6 cycles:

Cetuximab: 400mg/m2 on Day 1 of cycle 1; 250 mg/m2 once per week thereafter

Gemcitabine: 1000mg/m2 on Days 1 and 8 of each cycle

Carboplatin: AUC = 5, Day 1 of each cycle

IMC-A12: 6mg/kg once per week (on Days 1, 8 and 15 of each cycle)

Then for the maintenance period:

Cetuximab: 500mg/m2 once every 2 weeks IMC-A12: 10mg/kg once every 2 weeks

Biological: Cetuximab
400 mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter.
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of each cycle
Drug: Carboplatin
AUC = 5, Day 1 of each cycle
Biological: IMC-A12
6 mg/kg once per week (on Days 1, 8, and 15 of each cycle)
Gemcitabine, Carboplatin, Cetuximab: Active Comparator

Patients on this arm will receive the following treatment schedule for the first 6 cycles:

Cetuximab: 400mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter.

Gemcitabine: 1000mg/m2 on Days 1 and 8 of each cycle

Carboplatin: AUC = 5, Day 1 of each cycle

Then during the maintenance period:

Cetuximab: 500mg/m2 once every two weeks

Biological: Cetuximab
400 mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter.
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of each cycle
Drug: Carboplatin
AUC = 5, Day 1 of each cycle

Detailed Description:

Stratified, randomized, multicenter, open-label Phase 2 study of 80 patients with Stage IIIb or IV NSCLC who have not received previous chemotherapy in the metastatic setting. Patients will be stratified based on disease histology (squamous versus [vs.] nonsquamous), and randomized on a 1:1 basis to receive gemcitabine, carboplatin, cetuximab, and IMC-A12 (GCC + A12) or gemcitabine, carboplatin, and cetuximab (GCC).

A treatment cycle will be defined as 3 weeks for the first 18 weeks; a cycle will be defined as 2 weeks thereafter. Combination therapy will continue for a total of six 3-week cycles (18 weeks), after which patients will enter a maintenance phase.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IIIb or IV NSCLC
  • Has metastatic disease at time of study entry
  • Has a tumor measurable according to RECIST guidelines
  • Age ≥ 18 years
  • Has an ECOG performance status of 0 -1 (Karnofsky ≥ 80)
  • If patient has received prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization
  • Has adequate hematologic function as defined by absolute neutrophil count (ANC) and platelet count within normal limits
  • Has adequate hepatic function as defined by a total bilirubin ≤ 1.5 x the ULN, and AST and ALT ≤ 3 x the ULN (or ≤ 5 x the ULN in the presence of known liver metastases)
  • Has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance is ≥ 60 mL/min.
  • Has fasting serum glucose < 120mg/dL or below the ULN
  • Because the teratogenicity of IMC-A12 is not known, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Has uncontrolled brain metastases
  • Has leptomeningeal disease
  • Has received previous chemotherapy for NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization
  • Is receiving any other investigational agents
  • Has a history of treatment with other agents targeting the IGF or the EGF receptor
  • Has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-A12 or Cetuximab
  • Has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose < 120mg/dL or below the ULN) and that they are on a stable dietary or therapeutic regimen for this condition.
  • Has an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Is pregnant or lactating
  • Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870870

Contacts
Contact: Patricia Kellerhouse, BS 908 541 8250 patricia.kellerhouse@imclone.com

Locations
United States, Florida
M.D. Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Jennifer E Tseng, MD            
United States, Georgia
Georgia Cancer Specialists Recruiting
Atlanta, Georgia, United States, 30341
Principal Investigator: Mansoor Saleh, MD            
United States, New Mexico
University of New Mexico Cancer Treatment Center Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Julie Bauman, MD            
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Emily Wang     646-227-2820     wange@mskcc.org    
Principal Investigator: Naiyer Rizvi, MD            
Sponsors and Collaborators
ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers: CP13-0811
Study First Received: March 26, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00870870     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Tumors
Antibodies, Monoclonal
Stage IIIb Metastatic Non-Small Cell Lung Cancer
Stage IV Metastatic Non-Small Cell Lung Cancer

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Immunologic Factors
Cetuximab
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Antibodies, Monoclonal
Antibodies
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Cetuximab
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009