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Status:

COMPLETED

Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, 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 complete and partial response rates in patients with previously untreated, extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed small cell lung cancer
  • Previously untreated disease
  • No mixed histology
  • Extensive-stage disease
  • Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No symptomatic, untreated, or uncontrolled CNS metastases
  • CNS metastases previously treated with whole-brain radiotherapy allowed
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hepatic
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin normal
  • ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement)
  • Renal
  • Creatinine clearance ≥ 45 mL/min
  • Cardiovascular
  • No angina pectoris
  • No congestive heart failure within the past 3 months, unless ejection fraction \> 40%
  • No cardiac arrhythmia
  • No myocardial infarction within the past 3 months
  • No hypertension, including labile hypertension
  • Pulmonary
  • No interstitial pneumonia
  • No extensive and symptomatic interstitial fibrosis of the lung
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of poor compliance with antihypertensive medication
  • Able to take folic acid, cyanocobalamin (vitamin B\_12) supplementation, or dexamethasone
  • No uncontrolled diabetes
  • No serious condition that would preclude study participation
  • No clinically significant infection
  • No significant traumatic injury
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed \< 5 years prior to study entry
  • No seizure disorder
  • No other severe and/or uncontrolled medical condition
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunotherapy
  • No concurrent immunomodulating agents
  • Chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • No concurrent hormonal therapy
  • Radiotherapy
  • See Disease Characteristics
  • Prior palliative radiotherapy allowed
  • No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome
  • No concurrent radiotherapy
  • Surgery
  • More than 4 weeks since prior major surgery\* (i.e., laparotomy) or open biopsy
  • More than 2 weeks since prior minor surgery\* NOTE: \*Insertion of a vascular access device is not considered major or minor surgery
  • Other
  • More than 4 weeks since prior investigational therapy
  • No concurrent Hypericum perforatum (St. John's wort)
  • No concurrent inducers or inhibitors of CYP3A4
  • No concurrent medications that are metabolized by CYP3A4
  • No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment
  • No other concurrent cytostatic or cytotoxic agents

Exclusion

    Key Trial Info

    Start Date :

    February 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2009

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00227565

    Start Date

    February 1 2006

    End Date

    October 1 2009

    Last Update

    July 6 2016

    Active Locations (148)

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

    Page 1 of 37 (148 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Aurora Presbyterian Hospital

    Aurora, Colorado, United States, 80012

    3

    Boulder Community Hospital

    Boulder, Colorado, United States, 80301-9019

    4

    Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, United States, 80933