A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

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Detailed Description

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Conditions

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Small Cell Lung Cancer Carcinoma, Small Cell SCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)

Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

cisplatin

Intervention Type DRUG

Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

radiation

Intervention Type RADIATION

Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

Interventions

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pemetrexed

Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)

Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

Intervention Type DRUG

cisplatin

Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Intervention Type DRUG

radiation

Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

Intervention Type RADIATION

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* Measurable disease with diagnosis of Small Cell Lung Cancer.
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
* Patients must be at least 18 years of age and have at least a 12-week life expectancy.
* No prior chemotherapy and/or prior thoracic radiotherapy.
* Adequate pulmonary function and organ function.

Exclusion Criteria

* Patients with myocardial infarction within the preceding six months.
* Diagnosis of a serious concomitant systemic disorder.
* Prior radiotherapy to the lower neck or abdominal region.
* Significant weight loss.
* Concurrent administration of any other antitumor therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No