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

Sponsored by:	Sylvester Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00305786

Purpose

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	Intervention	Phase
Lung Cancer	Drug: gemcitabine hydrochloride Drug: oxaliplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as monitored by DSMC [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2005
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305786

Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136

Sponsors and Collaborators

Sylvester Cancer Center

Investigators

Study Chair:

Caio Max S. Rocha Lima, MD

Sylvester Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ( Caio Max S. Rocha Lima )
Study ID Numbers:	CDR0000464698, SCCC-2004078, SCCC-EPROST-20043597, SANOFI-SCCC-2004078, WIRB-20050485, SCCC-1066207
Study First Received:	March 21, 2006
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00305786
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Oxaliplatin
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Neoplasm Metastasis
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009