A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Patients With Lung Cancer Who Have Not Received Chemotherapy Before

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00870870
First received: March 26, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gemcitabine
Drug: Cisplatin
Biological: IMC-A12 (cixutumumab)
Biological: Cetuximab
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
    ORR is equal to the proportion of participants achieving the best overall response of confirmed partial (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST).


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
  • Time To Progression (TTP) [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: No ]
  • Summary of Adverse Events (AEs) [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: Yes ]
  • Serum Anti-IMC-A12 (cixutumumab) Assessment [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) at study day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) Cycle 1 [ Time Frame: Approximately week 1 (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) Cycle 3 [ Time Frame: Approximately week 7 (Cycle 3, Day 1) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) Cycle 5 [ Time Frame: Approximately week 13 (Cycle 5, Day 1) ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) at study day 1 [ Time Frame: Minimum concentration (Cmin) at study day 1 ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) Cycle 1 [ Time Frame: Approximately week 1 (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) Cycle 3 [ Time Frame: Approximately week 7 (Cycle 3, Day 1) ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) Cycle 5 [ Time Frame: Approximately week 13 (Cycle 5, Day 1) ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2009
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GCiC + IMC-A12 (cixutumumab)
Cycles Repeat every 3 weeks for 6 cycles (18 weeks)
Drug: Gemcitabine

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

(First 6 cycles [18 weeks])

Drug: Cisplatin

75 mg/m2 , day 1 of each cycle

(First 6 cycles [18 weeks])

Biological: IMC-A12 (cixutumumab)

6 mg/kg I.V. infusion, administered once per week (on Days 1, 8, and 15 of each cycle)

(First 6 cycles [18 weeks])

Other Name: Cixutumumab
Biological: Cetuximab

400 mg/m2 I.V. infusion, administered on Day 1 of Cycle 1, 250 mg/m2 once per week thereafter

(First 6 cycles [18 weeks])

Other Name: Erbitux®
Biological: IMC-A12 (cixutumumab)

10 mg/kg I.V. infusion, administered once every 2 weeks

[Maintenance period]

Other Name: Cixutumumab
Biological: Cetuximab

500 mg/m2 I.V. infusion, administered once every 2 weeks

[Maintenance period]

Other Name: Erbitux®
Drug: Carboplatin

AUC = 5, day 1 of each cycle

(First 6 cycles [18 weeks])

*Carboplatin will be replaced by Cisplatin

Active Comparator: GCiC (Gemcitabine/Cisplatin/Cetuximab)

Cycles Repeat every 3 weeks for 6 cycles (18 weeks)

*Cisplatin will replace Carboplatin, GCC will change to GCiC (Patients enrolled subsequent to this change will receive cetuximab, gemcitabine, and cisplatin)

Drug: Gemcitabine

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

(First 6 cycles [18 weeks])

Drug: Cisplatin

75 mg/m2 , day 1 of each cycle

(First 6 cycles [18 weeks])

Biological: Cetuximab

400 mg/m2 I.V. infusion, administered on Day 1 of Cycle 1, 250 mg/m2 once per week thereafter

(First 6 cycles [18 weeks])

Other Name: Erbitux®
Biological: Cetuximab

500 mg/m2 I.V. infusion, administered once every 2 weeks

[Maintenance period]

Other Name: Erbitux®
Drug: Carboplatin

AUC = 5, day 1 of each cycle

(First 6 cycles [18 weeks])

*Carboplatin will be replaced by Cisplatin


Detailed Description:

Participants with Stage IIIb or IV NSCLC who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus [vs.] nonsquamous).

  Eligibility

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

Inclusion Criteria:

  • Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
  • Has metastatic disease
  • Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Has adequate hematologic function
  • Has adequate hepatic function
  • Has adequate renal function
  • Women of childbearing potential 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

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)
  • Receiving any other investigational agent(s)
  • Has a history of treatment with other agents targeting the IGF or the EGF receptor
  • Has a known allergy / history of hypersensitivity reaction to any of the treatment components
  • 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 < 160 mg/dL or below the ULN and hemoglobin A1C ≤ 7%) and that they are on a stable dietary or therapeutic regimen for this condition
  • Has an uncontrolled intercurrent illness
  • 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
  • Has superior vena cava syndrome contraindicating hydration
  • Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
  • Has any NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy
  • Has significant third space fluid retention, requiring repeated drainage
  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: NCT00870870

Locations
United States, Alabama
ImClone Investigational Site
Anniston, Alabama, United States, 36207
United States, California
ImClone Investigational Site
La Jolla, California, United States, 92093
ImClone Investigational Site
Orange, California, United States, 92868
United States, Florida
ImClone Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
ImClone Investigational Site
Atlanta, Georgia, United States, 30341
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60637
ImClone Investigational Site
Chicago, Illinois, United States, 60612
United States, New Mexico
ImClone Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
ImClone Investigational Site
New York, New York, United States, 10021
ImClone Investigational Site
New York, New York, United States, 10011
ImClone Investigational Site
New York, New York, United States, 10032
United States, Ohio
ImClone Investigational Site
Cincinnati, Ohio, United States, 45247
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC
ClinicalTrials.gov Identifier: NCT00870870     History of Changes
Other Study ID Numbers: 13930, CP02-0860, CP13-0811, I5A-IE-JAEF
Study First Received: March 26, 2009
Last Updated: June 12, 2012
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

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
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

ClinicalTrials.gov processed this record on July 20, 2014