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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305786
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
University of Miami

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 2

Detailed Description:



  • Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.
  • Determine overall response in patients treated with this regimen.


  • Determine time to progression, time to treatment failure, and overall survival of these patients.
  • Determine the type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days after completion of study treatment.
  • Assess the quality of life of these patients.
  • Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of each course, at the completion of study treatment, and then every 6 weeks thereafter.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Response rate as measured by RECIST criteria [ Time Frame: At study completion ]

Secondary Outcome Measures :
  1. Toxicity as monitored by DSMC [ Time Frame: At study completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305786

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
University of Miami
Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center

Responsible Party: University of Miami Identifier: NCT00305786     History of Changes
Other Study ID Numbers: 20043597
SCCC-2004078 ( Other Identifier: University of Miami Institutional Review Board )
WIRB-20050485 ( Other Identifier: Western Institutional Review Board )
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by University of Miami:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs