Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

Phase 2CompletedNCT00192036

Eli Lilly and Company49 enrolled

Overview

The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

gemcitabineDRUG

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)

cisplatinDRUG

80 mg/m2, IV, every 21 days x 5 cycles

radiationRADIATION

63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inoperable non small cell lung cancer Stage III * Adequate hematological parameters * Adequate Lung function reserve Exclusion Criteria: * Previous chemotherapy and thoracic radiation for non small cell lung cancer * Presence of distant metastases

Locations (8)

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.

Aalst, Belgium

Outcomes

Primary Outcomes

Tumor Response at End of Treatment

Response recorded at the first follow-up visit 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 first follow-up visit (up to 8 weeks after end of chemo-radiation)

Secondary Outcomes

Time to Progressive Disease

Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.

Time frame: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);

Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time frame: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)

Safety of Induction Chemotherapy

A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.

Time frame: every cycle (21 days) for 3 cycles (up to 10 weeks)

Data from ClinicalTrials.gov

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