TerminatedPhase 2NCT00281827

Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.

Checked against the public recordLast updated Dec 28, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations3
SponsorMasonic Cancer Center, University of Minnesota
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Masonic Cancer Center, University of Minnesota
Interventions being studied
Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: thalidomide; Procedure: conventional surgery
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

Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes: * Squamous cell carcinoma * Adenocarcinoma * Large cell undifferentiated carcinoma * Stage II or IIIA disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan * No tumor involving the superior sulcus (e.g., Pancoast tumor) * Karnofsky performance status 70-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2 mg/dL * Bilirubin \< 2 mg/dL * Aspartate aminotransferase (AST) \< 3 times upper limit of normal Exclusion Criteria: * Pregnant or nursing * No nursing during and for ≥ 4 weeks after completion of study treatment * Positive pregnancy test * Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment * Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment * Blood, sperm, or ova donation during study treatment * Post obstructive pneumonia * Other serious infection or medical illness that would preclude study participation * Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years * Less than 5 years since prior resection of lung disease * Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC) * Other concurrent chemotherapy or radiotherapy * Concurrent hormonal therapy or immunotherapy * Other concurrent anticancer therapy * Other concurrent investigational agents * Concurrent participation in another clinical 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 Minnesota Cancer CenterMinneapolis, Minnesota
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 28, 2017. Always confirm current availability with the study team.

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