CompletedPhase 2NCT00227565

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

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 dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations148
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: pemetrexed disodium; Radiation: radiation
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 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

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

  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • Aurora Presbyterian HospitalAurora, Colorado
  • Boulder Community HospitalBoulder, Colorado
  • Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
  • St. Anthony Central HospitalDenver, Colorado
  • Porter Adventist HospitalDenver, Colorado
  • Presbyterian - St. Luke's Medical CenterDenver, Colorado
  • St. Joseph HospitalDenver, Colorado
  • Rose Medical CenterDenver, Colorado
  • CCOP - Colorado Cancer Research ProgramDenver, Colorado
  • Swedish Medical CenterEnglewood, Colorado
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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