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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Cetuximab
Sponsored by
Nasser Hanna, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical & Surgical Specialists, LLC
  • Cancer Care Center of Southern Indiana
  • Elkhart Clinic
  • Fort Wayne Oncology & Hematology, Inc
  • Center for Cancer Care at Goshen Health System
  • Indiana University Cancer Center
  • Medical Consultants, P.C.
  • Northern Indiana Cancer Research Consortium
  • Greenebaum Cancer Center
  • Oncology Hematology Care, Inc.
  • Texas Oncology Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
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
Time To Progression (TTP)
The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Secondary Outcome Measures

Median Survival Time
Toxicity and Safety Profile
Clinical Benefit Rate
Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)

Full Information

First Posted
September 12, 2005
Last Updated
August 22, 2016
Sponsor
Nasser Hanna, M.D.
Collaborators
Eli Lilly and Company, Bristol-Myers Squibb, Walther Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00216203
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nasser Hanna, M.D.
Collaborators
Eli Lilly and Company, Bristol-Myers Squibb, Walther Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Treatment
Arm Type
Experimental
Arm Description
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
Description
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
Time Frame
12 months
Title
Time To Progression (TTP)
Description
The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Median Survival Time
Time Frame
24 Months
Title
Toxicity and Safety Profile
Time Frame
12 months
Title
Clinical Benefit Rate
Description
Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Hanna, M.D.
Organizational Affiliation
Hoosier Oncology Group, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Medical & Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Cancer Care Center of Southern Indiana
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Elkhart Clinic
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Oncology & Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Center for Cancer Care at Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46527
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Medical Consultants, P.C.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19701110
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.
Results Reference
result
Links:
URL
http://hoosieroncologygroup.org/
Description
Hoosier Oncology Group Home Page

Learn more about this trial

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

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