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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305786
• Other study ID #: 20043597
• Secondary ID: SCCC-2004078WIRB
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2006
• Last updated: December 14, 2016
• Start date: August 2005
• Est. completion date: May 2010

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by RECIST criteria		At study completion	No
Secondary	Toxicity as monitored by DSMC		At study completion	Yes