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

University of Miami

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00305786

SCCC-2004078 (Other Identifier)

WIRB-20050485 (Other Identifier)

20043597

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

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.

Secondary

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.

Enrollment

30 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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