Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer

NCT ID: NCT00216203

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-12-31

Brief Summary

Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

Detailed Description

OUTLINE: This is a multi-center study.

Week 1 (day 1):

• Cetuximab 400mg/m2

Week 2 (Cycle 1, Day 1):

• Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.

Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.

Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.

Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks

Hematopoietic:

• ANC > 1,500/mm3
• Platelets > 100,000/mm3

Hepatic:

• Bilirubin less than or equal to the upper limit of normal (ULN)
• Aspartate aminotransferase (AST) < 1.5 X ULN. AST may be < 5 X ULN for patients with liver metastases
• Alkaline phosphatase < 5 X ULN

Renal:

• Calculated creatinine clearance > 45 mL/min (by Cockcroft-Gault)

Cardiovascular:

• No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)

Pulmonary:

• Not specified

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational Treatment

Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles

Cetuximab

Intervention Type: DRUG

Cetuximab 400 mg/m2, week 1, day 1

Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Interventions

Pemetrexed

Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles

Intervention Type: DRUG

Cetuximab

Cetuximab 400 mg/m2, week 1, day 1

Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic or cytologic diagnosis of NSCLC
• Recurrent or metastatic disease that is not amenable to curative therapyMeasurable disease according to RECIST
• At least one prior platinum containing regimen for either locally advanced or metastatic disease
• Prior chemotherapy must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen
• Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period
• Prior radiation therapy allowed to < 25% of the bone marrow
• Negative pregnancy test

Exclusion Criteria

• No active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
• No serious concomitant systemic disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 2 years.
• No major thoracic or abdominal surgery within 30 days prior to being registered for protocol therapy.
• No current breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Walther Cancer Institute

OTHER

Sponsor Role: collaborator

Nasser Hanna, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Nasser Hanna, M.D.

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nasser Hanna, M.D.

Role: STUDY_CHAIR

Hoosier Oncology Group, LLC

Locations

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Elkhart Clinic

Elkhart, Indiana, United States

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States

Center for Cancer Care at Goshen Health System

Goshen, Indiana, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Medical Consultants, P.C.

Muncie, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Greenebaum Cancer Center

Baltimore, Maryland, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Texas Oncology Cancer Center

Austin, Texas, United States

Countries

United States

References

Jalal S, Waterhouse D, Edelman MJ, Nattam S, Ansari R, Koneru K, Clark R, Richards A, Wu J, Yu M, Bottema B, White A, Hanna N. Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC): a phase I/II study from the Hoosier Oncology Group. J Thorac Oncol. 2009 Nov;4(11):1420-4. doi: 10.1097/JTO.0b013e3181b624ae.

Reference Type: RESULT

PMID: 19701110 (View on PubMed)

Related Links

http://hoosieroncologygroup.org/

Hoosier Oncology Group Home Page

Other Identifiers

HOG LUN04-79

Identifier Type: -

Identifier Source: org_study_id