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Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease



- 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

- 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.

Inclusion Criteria


- 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

- 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

- No peripheral neuropathy > grade 1

- No history of hypersensitivity to study drugs

- No serious uncontrolled medical or psychiatric illness, including any of the

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured by RECIST criteria

Outcome Time Frame:

At study completion

Safety Issue:


Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

May 2010

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136