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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216203
• Other study ID #: HOG LUN04-79
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: February 17, 2016
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
• Cetuximab
Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Locations

Country	Name	City	State
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Greenebaum Cancer Center	Baltimore	Maryland
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Elkhart Clinic	Elkhart	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
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

Sponsors (5)

Lead Sponsor	Collaborator
Nasser Hanna, M.D.	Bristol-Myers Squibb, Eli Lilly and Company, ImClone LLC, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Onc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab		12 months	Yes
Primary	The primary objective of the phase II portion is to estimate the time to progression of this combination		12 months	No
Secondary	The secondary objectives of the phase II portion are to estimate the clinical benefit rate (CR + PR + SD lasting more than 90 days), median survival time and to further characterize the toxicity profile of this combination		12 months	Yes

External Links

•   Hoosier Oncology Group Home Page