Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 306
Healthy volunteers: no

Brief summary:
RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cediranib is more effective than a placebo when given together with paclitaxel and carboplatin in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well cediranib works when given together with paclitaxel and carboplatin in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carboplatin.

Secondary

* To compare the progression-free survival of patients treated with these regimens.
* To compare the objective response rates in patients treated with these regimens.
* To estimate time to response and response duration in patients treated with these regimens.
* To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis, in patients treated with these regimens.
* To compare the pharmacokinetics of paclitaxel between the two arms in a subset of enrolled patients
* To compare the quality of life of patients treated with these regimens.
* To determine the incremental cost effectiveness and cost utility ratios for these regimens.
* To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion OUTLINE: This is a multicenter study. Patients are stratified by gender, center, disease stage (IIIB vs IV), weight loss (\< 5% vs 5-10% vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.

Treatment in both arms repeats every 21 days for 4 to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of each course, and periodically thereafter.

After completion of study therapy, patients are followed every 12 weeks.

Arms:
arm 1: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. arm 2: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.

Interventions: intervention 1: carboplatin intervention 2: cediranib maleate intervention 3: paclitaxel intervention 4: placebo
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally intervention 3: Given IV intervention 4: Given orally

Protocol document: