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

Phase 2TerminatedNCT00447421

Eli Lilly and Company9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer Carcinoma, Small Cell SCLC

Interventions

pemetrexedDRUG

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

cisplatinDRUG

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

radiationRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leuven, Belgium

's-Hertogenbosch, Netherlands

Outcomes

Primary Outcomes

Phase 1: Maximum Tolerated Dose

Time frame: every cycle

Phase 2: Overall Response Rate

Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.

Time frame: baseline to measured progressive disease

Secondary Outcomes

Phase 1: Best Overall Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Time frame: baseline to measured response

Phase 2: Complete Response Rate

Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.

Time frame: baseline to measured response time

Phase 2: Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.

Time frame: baseline to measured progressive disease

Phase 2: Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Data from ClinicalTrials.gov

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