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A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed advanced (Stage IIIB
with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous
NSCLC.

- Patients must have at least one measurable disease per RECIST criteria

- Patient must have disease progression after one prior chemotherapy and/or targeted
therapy other than pemetrexed or anti-EGFR therapy for metastatic disease, or relapse
while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy

Exclusion Criteria:

- Patients who have had immunotherapy, hormone, chemotherapy or radiotherapy within 4
weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those
who have not recovered from adverse events due to agents administered more than 4
weeks earlier.

- Patients with uncontrolled brain metastases should be excluded from this clinical
trial because of their poor prognosis.

- Patients with immune deficiency

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Tianhong Li, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

Pemetrexed/Erlotinib

NCT ID:

NCT00950365

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • progressive or recurrent stage III or stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490
Albert Einstein Cancer CenterBronx, New York  10461
University of MassachusettsWorcester, Massachusetts  01655