Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
University of Colorado, Denver
Greenwich Hospital
IUPUI, Indianapolis, IN
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00034541
First received: April 30, 2002
Last updated: April 8, 2010
Last verified: April 2010
  Purpose

The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Biological: cetuximab
Drug: paclitaxel
Drug: carboplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antitumor activity [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: December 2000
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
An initial dose of cetuximab (400 mg/m2 i.v. over 120 minutes) will be administered 1 week prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each cycle (every 3 weeks) of therapy, a 3-hour paclitaxel (225 mg/m2) infusion will be administered 1-hour post completion of the cetuximab infusion, immediately followed by a 30-minute carboplatin (AUC=6) infusion.
Biological: cetuximab
400 mg/m2 i.v. over 120 minutes
Other Name: Erbitux
Drug: paclitaxel
225 mg/m2, infusion
Other Name: Taxol
Drug: carboplatin
30-minute AUC = 6, infusion.
Other Name: Paraplatin

Detailed Description:

The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.

  Eligibility

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

Inclusion Criteria:

The following inclusion criteria must be met:

  • The patient has stage IV NSCLC with either present or prior histologic or pathologic confirmation of NSCLC
  • The patient has uni-dimensionally measurable stage IV NSCLC
  • The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent disease if prior radiation therapy was received. Pathological confirmation of recurrence is required for disease within a radiation portal.
  • The patient's ECOG performance status is ≤ 2 at study entry.
  • The patient has immunohistochemical evidence of EGFr expression (≥1+). Patients who do not have tumor tissue available for EGFr testing will undergo a biopsy of an accessible tumor. EGFr expression must be confirmed prior to study entry.
  • The patient has given signed informed consent.
  • The patient is 18 years of age or older.
  • The patient has adequate hematologic function, as defined by an absolute neutrophil (ANC)≥ 1,500/mL3 , a WBC count≥3,000/mL3, a platelet count ≥100,000/mL3, and a hemoglobin level ≥9g/dL.
  • The patient has adequate hepatic function as defined by a total bilirubin level ≤1.5 X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level ≤2.5 X the ULN.
  • The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute.
  • The patient is disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years (patients with a history of a previous basal cell carcinoma of the skin or preinvasive carcinoma of the cervix will not be excluded).
  • The patient, if a woman, agrees to use effective contraception if childbearing potential exists. The patient, if a man, agrees to use effective contraception.

Exclusion Criteria:

The following ten exclusion criteria are for this study:

  • The patient has received prior cetuximab therapy.
  • The patient has disease amenable to curative surgery.
  • The patient has received prior chemotherapy for the disease under study.
  • The patient has received wide field radiation therapy within 4 weeks prior to the first infusion of cetuximab. The patient may have local irradiation for the management of tumor-related symptoms.
  • The patient has undergone major thoracic or abdominal surgery within 30 days (to allow for a full recovery)prior to the first infusion of cetuximab.
  • The patient has a history of uncontrolled angina,arrhythmias, or congestive heart failure.
  • The patient has uncontrolled seizure disorder, active neurological disease (not tumor related), or grade ≥2 neuropathy (patients with meningeal or central nervous system [CNS] involvement by the tumor will be eligible).
  • The patient has a history of hypersensitivity to Cremophor EL.
  • The patient, if a woman, is pregnant (confirmed by serum BHCG) or breastfeeding.
  • The patient has received any investigation agents within 30 days of study entry.
  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: NCT00034541

Locations
United States, Colorado
ImClone Investigational Site
Denver, Colorado, United States, 80262
United States, Connecticut
ImClone Investigational Site
Greenwich, Connecticut, United States, 06830
United States, Indiana
ImClone Investigational Site
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
ImClone LLC
University of Colorado, Denver
Greenwich Hospital
IUPUI, Indianapolis, IN
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

Publications:
Kelly K, Hanna N, Rosenberg A, Bunn PA, Needle MN. A multi-centered phase I/II study of cetuximab in combination with paclitaxel and carboplatin in untreated patients with stage IV non-small cell lung cancer (Abstract 2592). American Society of Clinical Oncology Annual Meeting. 2003 May 31-June 3; Chicago, Illinois.

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00034541     History of Changes
Other Study ID Numbers: CP02-9932
Study First Received: April 30, 2002
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
cetuximab
epidermal growth factor receptor
antibody
non-small cell lung cancer
carboplatin
paclitaxel

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Cetuximab
Carboplatin
Mitogens
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014