Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

Phase 2CompletedNCT00191139

Eli Lilly and Company64 enrolled

Overview

To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

gemcitabineDRUG

After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.

docetaxelDRUG

Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

cisplatinDRUG

As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * histologic or cytologic proof of single primary non-small cell lung cancer * No prior chemotherapy or radiation therapy * no prior malignancy Exclusion Criteria: * pregnancy or breastfeeding * serious concomitant systemic disorder * unintentional weight loss greater than 10%

Locations (15)

Outcomes

Primary Outcomes

2-Year Survival

Percentage of participants alive at 2 years.

Time frame: 2 years

Secondary Outcomes

Number of Patients With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).

Time frame: randomization and every 3 months up to 2 years of post-study followup

Progression-Free Survival

Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.

Time frame: baseline to measured progressive disease up to 2057 days

Overall Survival

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

Time frame: baseline to date of death from any cause up to 2057 days

Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

LCSS measures physical \& functional dimensions. The patient scale contains 9 items, 3 summation \& 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.

Data from ClinicalTrials.gov

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Denver, Colorado, United States

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Portland, Oregon, United States

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Memphis, Tennessee, United States

...and 5 more locations