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

N

Nasser Hanna, M.D.

Status and phase

Completed
Phase 2
Phase 1

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Pemetrexed
Drug: Cetuximab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00216203
HOG LUN04-79

Details and patient eligibility

About

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.

Full 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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Investigational Treatment
Experimental group
Description:
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Treatment:
Drug: Cetuximab
Drug: Pemetrexed

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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