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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jyoti Patel, Northwestern University
ClinicalTrials.gov Identifier:
NCT00234052
First received: October 5, 2005
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: carboplatin
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Median time to progression [ Time Frame: Approximately every 3 weeks until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate and duration of response [ Time Frame: After 6 cycles of therapy (cycle = 3 weeks) and then after every cycle until disease progression ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After every cycle of therapy (cycle = 3 weeks) ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2005
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Carboplatin + pemetrexed + bevacizumab
Biological: bevacizumab
5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
Other Name: Avastin
Drug: carboplatin
Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
Drug: pemetrexed
Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
Other Name: pemetrexed disodium

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234052

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Jyoti D. Patel Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Jyoti Patel, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00234052     History of Changes
Other Study ID Numbers: NU 04L2, NU-04L2, STU00007415
Study First Received: October 5, 2005
Last Updated: April 30, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014