Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of pemetrexed disodium, gemcitabine hydrochloride, and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer.

Secondary

* Determine the response rate in patients treated with this regimen.
* Determine the time to treatment failure in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes, gemcitabine hydrochloride IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Arms:
arm 1: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days

Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.

Interventions: intervention 1: bevacizumab intervention 2: gemcitabine hydrochloride intervention 3: pemetrexed disodium
Intervention descriptions: intervention 1: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days intervention 2: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days intervention 3: Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.

Protocol document: