CompletedPhase 2NCT00305786

Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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 gemcitabine together with oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.

Checked against the public recordLast updated Dec 15, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations2
SponsorUniversity of Miami
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Miami
Interventions being studied
Drug: gemcitabine hydrochloride; Drug: oxaliplatin
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 proven stage IIIB or IV non-small cell lung cancer (NSCLC) * Failed first-line chemotherapy * Must have received ≥ 1, but no more than 2, prior chemotherapy regimens for stage IIIB or IV NSCLC * Prior radiotherapy or surgery for earlier stage disease allowed, provided target lesions chosen for response assessment have not have been irradiated * At least 1 unidimensionally measurable lesion with diameter ≥ 20 mm by conventional methods OR ≥ 10 mm by spiral CT scan * If a single lesion is identified as the target lesion, histological or cytological confirmation of this lesion is required * No symptomatic brain metastases * Clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone allowed PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after completion of study treatment * No history of an acute cardiac or CNS event within the past 6 months, including any of the following: * Unstable angina * Myocardial infarction * Clinically relevant arrhythmia * Stroke * No current clinical evidence of congestive heart failure or unstable coronary artery disease * No peripheral neuropathy \> grade 1 * No history of hypersensitivity to study drugs * No serious uncontrolled medical or psychiatric illness, including any of the following: * Serious infection * Interstitial pneumonia * Extensive and symptomatic fibrosis of the lung * No other malignancy within the past year, except for squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * At least 4 weeks since prior cranial radiation for brain metastases * More than 4 weeks since prior participation in another investigational drug study * No concurrent immunotherapy

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 Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida
  • H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 15, 2016. Always confirm current availability with the study team.

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