Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT00234052 | Completed Phase 2 Results

• 3 other identifiers: NU 04L2NU-04L2STU00007415
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; 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

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival

  Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.

  Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)

Secondary Outcomes (4)

• Overall Response Rate

  Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)

• Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment

  From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)

• Overall Survival Rate

  During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.

• Duration of Response

  From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Carboplatin + pemetrexed + bevacizumab

Biological: bevacizumab; Drug: carboplatin; Drug: pemetrexed

Interventions

bevacizumab BIOLOGICAL

5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)

Also known as: Avastin

Treatment Arm

carboplatin DRUG

Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)

Treatment Arm

pemetrexed DRUG

Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)

Also known as: pemetrexed disodium

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Bevacizumab; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Clinical Trials Office
• Organization: Northwestern University

312-695-1301

Study Officials

• Jyoti D. Patel

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 6, 2005
• Study Start: July 28, 2005
• Primary Completion: March 1, 2011
• Study Completion: November 28, 2011
• Last Updated: June 4, 2019
• Results First Posted: May 16, 2019

Record last verified: 2019-01

Locations

US (5)