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Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer


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

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Trial Information

Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer


Two 21-day cycles of pemetrexed (500 milligrams per square meter [mg/m2] intravenous [IV]
infusion) and carboplatin (target area under the curve [AUC] 5 IV infusion) followed by two
21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV
infusion) with concurrent radiotherapy (2 Gray [Gy] per fraction, 5 fractions per week, up
to a dose of 50 Gy is administered).


Inclusion Criteria:



- Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer

- Measurable disease

- Good performance status

- Adequate bone marrow reserve, hepatic, pulmonary and renal functions

Exclusion Criteria:

- Serious concomitant systemic disorder

- Prior chemotherapy for this cancer and/or prior thoracic radiotherapy

- Pregnancy/breast-feeding

- Significant weight loss over the previous 6 weeks before study entry

- Inability or unwillingness to take vitamin supplementation and corticosteroids

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:

Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])

Outcome Time Frame:

baseline to measured response after chemotherapy and radiation

Safety Issue:

No

Principal Investigator

Call 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:

Italy: Ministry of Health

Study ID:

10015

NCT ID:

NCT00494026

Start Date:

September 2007

Completion Date:

October 2008

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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