CompletedPhase 2 / Phase 3NCT00006229

Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more effective with or without BMS-275291 for non-small cell lung cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer.

Checked against the public recordLast updated Apr 6, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2 / Phase 3
U.S. locations69
SponsorNCIC Clinical Trials Group
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
NCIC Clinical Trials Group
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Drug: rebimastat
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) * Local or metastatic failure after surgery and/or radiotherapy allowed * Phase II only: * At least one measurable lesion * At least 20 mm by conventional techniques OR 10 mm by spiral CT scan * No known CNS metastases unless asymptomatic and at least 4 weeks since prior corticosteroid therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2 times ULN (5 times ULN for liver metastases) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiac disease * No uncontrolled high blood pressure, unstable angina, congestive heart failure, second or third degree atrioventricular conduction defects, or ventricular arrhythmias requiring medication * No myocardial infarction within the past year Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction to drugs containing Cremophor EL * No serious active infection or other underlying medical condition that would preclude study participation * No peripheral neuropathy * No condition (e.g., psychological, geographical) that would preclude study participation * No prior breast cancer or melanoma * No other prior malignancy within the past 5 years except carcinoma in situ, basal cell or squamous cell skin cancer, or other cancer that has been curatively treated surgically PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy * No prior biological response modifiers * No other concurrent biologic therapy or immunotherapy Chemotherapy: * No prior antineoplastic chemotherapy, including intrapleural chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * No prior radiotherapy to study lesion (unless evidence of disease progression) or to 30% or greater of marrow bearing bones * At least 1 week since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 2 weeks since prior major surgery * No concurrent surgery Other: * At least 2 weeks since prior investigational drugs * No other concurrent cytotoxic anticancer therapy * No other investigational drugs during and for 30 days after study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama
  • University of Arkansas for Medical SciencesLittle Rock, Arkansas
  • Scripps ClinicLa Jolla, California
  • Central Georgia Hematology Oncology, P.C.Macon, Georgia
  • Queen's Medical CenterHonolulu, Hawaii
  • Carle Cancer CenterUrbana, Illinois
  • Lahey Clinic - BurlingtonBurlington, Massachusetts
  • Creighton University Cancer CenterOmaha, Nebraska
  • Duke University Medical CenterDurham, North Carolina
  • University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma
  • Erlanger Health SystemsChattanooga, Tennessee
  • Memorial Hospital Cancer Center - ChattanoogaChattanooga, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2020. Always confirm current availability with the study team.

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