Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments bevacizumab, carboplatin, pemetrexed
Phase phase 2
Target VEGF
Sponsor Northwestern University
Collaborator National Cancer Institute (NCI)
Start date June 2005
End date May 2016
Trial size 50 participants
Trial identifier NCT00234052, NU 04L2, NU-04L2, STU00007415

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Carboplatin + pemetrexed + bevacizumab
bevacizumab Avastin
5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
carboplatin
Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
pemetrexed pemetrexed disodium
Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)

Primary Outcomes

Measure
Median time to progression
time frame: Approximately every 3 weeks until disease progression

Secondary Outcomes

Measure
Response rate and duration of response
time frame: After 6 cycles of therapy (cycle = 3 weeks) and then after every cycle until disease progression
Toxicity
time frame: After every cycle of therapy (cycle = 3 weeks)
Determine overall survival rate
time frame: After every cycle during treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically* or cytologically* confirmed non-small cell lung cancer - Any histology, except squamous cell carcinoma, allowed - Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible - No histology in close proximity to a major vessel or cavitation NOTE: *Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy - Meets 1 of the following stage criteria: - Stage IIIB disease (with malignant pleural effusion) - Stage IV disease - Recurrent disease - Measurable or non-measurable disease - No known CNS metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 - No history of hemorrhagic disorders Hepatic - Bilirubin < 1.5 mg/dL - AST and ALT < 5 times upper limit of normal - INR < 1.5 - PTT normal Renal - Creatinine clearance ≥ 45 mL/min - Urine protein:creatinine ≤ 1.0 by spot urinalysis Cardiovascular - No myocardial infarction within the past 6 months - No New York Heart Association class II-IV congestive heart failure - No unstable angina pectoris - No serious cardiac arrhythmia requiring medication - No stroke within the past 6 months - No peripheral vascular disease ≥ grade 2 - No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) - Patients with a history of hypertension allowed provided blood pressure is well controlled on a stable regimen of anti-hypertensive therapy - No history of thrombotic disorders - No other clinically significant cardiovascular disease Pulmonary - No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Must be willing and able to take daily oral folic acid, intermittent vitamin B_12 injections, and corticosteroid premedication - No ongoing or active infection - No serious, non-healing wound, ulcer, or bone fracture - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 weeks since prior immunotherapy Chemotherapy - No prior systemic chemotherapy Endocrine therapy - More than 3 weeks since prior hormonal therapy Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy Surgery - More than 4 weeks since prior major surgery - More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy - No concurrent major surgery Other - Recovered from all prior therapy - More than 4 weeks since prior and no concurrent participation in another experimental drug study - No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen, rofecoxib, or celecoxib]) - No concurrent therapeutic anticoagulation - Concurrent prophylactic anticoagulation for venous access devices allowed provided requirements for INR and PTT are met - No concurrent administration of any of the following: - Chronic daily treatment with aspirin (> 325 mg per day) - NSAIDs known to inhibit platelet function, including any of the following: - Dipyridamole - Ticlopidine - Clopidogrel - Cilostazol

Additional Information

Official title Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Description OBJECTIVES: Primary - Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab. Secondary - Determine the response rate and duration of response in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Northwestern University.