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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
Sponsored by
University of Miami
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Outcomes

Primary Outcome Measures

Response rate as measured by RECIST criteria

Secondary Outcome Measures

Toxicity as monitored by DSMC

Full Information

First Posted
March 21, 2006
Last Updated
December 14, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00305786
Brief Title
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Response rate as measured by RECIST criteria
Time Frame
At study completion
Secondary Outcome Measure Information:
Title
Toxicity as monitored by DSMC
Time Frame
At study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caio Max S. Rocha Lima, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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