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

NCT00034541 | Completed Phase 1

• 1 other identifier: CP02-9932
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

cetuximab; epidermal growth factor receptor; antibody; non-small cell lung cancer; carboplatin; paclitaxel

Outcome Measures

Primary Outcomes (1)

• Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin

  8 Weeks

Secondary Outcomes (2)

• Antitumor activity

  8 Weeks

• Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin

  8 Weeks

Study Arms (1)

1

EXPERIMENTAL

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; Drug: paclitaxel; Drug: carboplatin

Interventions

cetuximab BIOLOGICAL

400 mg/m2 i.v. over 120 minutes

Also known as: Erbitux

1

paclitaxel DRUG

225 mg/m2, infusion

Also known as: Taxol

1

carboplatin DRUG

30-minute AUC = 6, infusion.

Also known as: Paraplatin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• University of Colorado, Denver: collaborator
• Greenwich Hospital: collaborator
• Indiana University: collaborator

Study Sites (3)

ImClone Investigational Site

Denver, Colorado, 80262, United States

Location

ImClone Investigational Site

Greenwich, Connecticut, 06830, United States

Location

ImClone Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Thienelt CD, Bunn PA Jr, Hanna N, Rosenberg A, Needle MN, Long ME, Gustafson DL, Kelly K. Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2005 Dec 1;23(34):8786-93. doi: 10.1200/JCO.2005.03.1997. Epub 2005 Oct 24.

  PMID: 16246975 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2002
• First Posted: May 1, 2002
• Study Start: December 1, 2000
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: April 9, 2010

Record last verified: 2010-04

Locations

US (3)