Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

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 divid...

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, pemetrexe...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 28 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 28 2011

    Estimated Enrollment :

    51 Patients enrolled

    Trial Details

    Trial ID

    NCT00234052

    Start Date

    July 28 2005

    End Date

    November 28 2011

    Last Update

    June 4 2019

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    2

    Rush Cancer Institute at Rush University Medical Center

    Chicago, Illinois, United States, 60612

    3

    Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, United States, 60201-1781

    4

    Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, United States, 60426

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