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A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients


Phase 2
70 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients


Inclusion Criteria:



- Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to
radiotherapy treatment) or Stage IV

- No previous chemotherapy for lung cancer

- Men and women > or = 70 years

- At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In
Solid Tumors [RECIST]criteria)

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

Exclusion Criteria:

- Treatment within the last 30 days with a drug that has not received regulatory
approval

- Serious systemic disorders

- Inability to discontinue administration of aspirin or anti-inflammatory non steroid

- Concurrent administration of any other antitumor therapy

- Brain metastasis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)

Outcome Description:

Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.

Outcome Time Frame:

baseline to measured objective tumor response (up to six 21-day cycles)

Safety Issue:

No

Principal Investigator

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

9941

NCT ID:

NCT00350792

Start Date:

August 2006

Completion Date:

November 2009

Related Keywords:

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

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