Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer

NCT00203931 | Terminated Phase 2 Results DMC

• 1 other identifier: 13722A
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine in patients with Non Small Cell Lung Cancer refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.

  Up to 5 years

Secondary Outcomes (4)

• Progression-free Survival Based on Rash Development

  up to 5 years

• Objective Response Rate

  up to 2 years

• Overall Survival

  Up to 5 years

• Progression-free Survival Based on Serum Biomarker Status

  up to 5 years

Study Arms (2)

Cetuximab

ACTIVE COMPARATOR

Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.

Drug: Cetuximab

Cetuximab and Pemetrexed

EXPERIMENTAL

Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.

Drug: Cetuximab; Drug: Pemetrexed

Interventions

Cetuximab DRUG

Also known as: ERBITUX

Cetuximab; Cetuximab and Pemetrexed

Pemetrexed DRUG

Also known as: ALIMTA

Cetuximab and Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
• ECOG performance status 0-2
• Patients must have been previously treated with one platinum-containing or taxane-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
• No more than two prior systemic anti-cancer therapies will be allowed.
• Prior radiation therapy is allowed to \<25% of the bone marrow. Prior radiation to the whole pelvis is not allowed, Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
• Patients must have signed an approved informed consent.
• Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for 3 months after the study. Female patients must either not be of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• Age\>18
• Measurable disease in accord with RECIST criteria
• Bone marrow Function: absolute neutrophil count (ANC)\>/=1,500/ul, platelets \>/=l00,000, hemoglobin\> 9g/dL
• Renal function: creatinine clearance (calculated by Cockcroft and Gault method) \>/= 45mL/min
• Hepatic function: bilirubin \</=1.5 x ULN; ALT/AST ,/= 2.5 x ULN; Albumin \>/=2.5 g/dL

You may not qualify if:

• Prior treatment with pemetrexed
• Prior therapy that targets the EGF pathway.
• Active or uncontrolled infection.
• Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
• Pleural or pericardial effusions that cannot be completely evacuated prior to pemetrexed therapy.
• Acute hepatitis or known HIV.
• Prior severe infusion reaction to a monoclonal antibody.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
• Pregnancy or Breast-feeding.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
• Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Sponsors & Collaborators

• University of Chicago: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Maitland ML, Levine MR, Lacouture ME, Wroblewski KE, Chung CH, Gordon IO, Szeto L, Ratko G, Soltani K, Kozloff MF, Hoffman PC, Salgia R, Carbone DP, Karrison TG, Vokes EE. Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancer. BMC Cancer. 2014 Jan 4;14:5. doi: 10.1186/1471-2407-14-5.

  PMID: 24386952 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Pemetrexed

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; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Kristen Wroblewski
• Organization: University of Chicago

kwroblewski@health.bsd.uchicago.edu

773-702-7173

Study Officials

• Michael Maitland, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: March 31, 2014
• Results First Posted: March 31, 2014

Record last verified: 2014-02

Locations

US (1)