Clinical trial NCT00216203: Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Bristol-Myers Squibb
name: Walther Cancer Institute
First posted: 2005-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
timeFrame: 12 months
measure: Time To Progression (TTP)
timeFrame: 24 Months
Secondary outcomes:
measure: Median Survival Time
timeFrame: 24 Months
measure: Toxicity and Safety Profile
timeFrame: 12 months
measure: Clinical Benefit Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Galesburg
country: United States
facility: Medical & Surgical Specialists, LLC
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center of Southern Indiana
state: Indiana
city: Elkhart
country: United States
facility: Elkhart Clinic
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Baltimore
country: United States
facility: Greenebaum Cancer Center
state: Maryland
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Nasser Hanna, M.D.
role: STUDY_CHAIR
References:
citation: 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.