- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276588
Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel 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 carboplatin followed by paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in regard to response rate, median survival, and one year survival.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is multicenter study.
- Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. In week 7, all patients proceed to part 2 regardless of disease response.
- Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed non-small lung cancer (NSCLC) of any of the following histologic types:
- Squamous cell
- Adenocarcinoma
- Large cell carcinoma
- Unspecified
Evidence of at least 1 of the following criteria:
- Newly diagnosed inoperable stage IIIB (pleural effusion) disease
- Patients with stage III disease who are unable to undergo combined modality therapy
- Stage IV disease
- Recurrent non-small cell lung cancer regardless of site
- Diagnosis based on sputum cytology acceptable if confirmed by an independent pathologic review
Patients must have measurable or evaluable disease
- Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present
- Patients with brain metastases are eligible, provided they are either asymptomatic (no neurological symptoms or signs, no evidence of midline shift), or controlled (i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid therapy for at least two weeks with no evidence of progression by symptoms or radiologic imaging
PATIENT CHARACTERISTICS:
- ECOG performance status of 2 or 3 OR HIV-positive OR underwent prior status post organ transplantation
- No active serious infection (except for HIV infection)
- No symptomatic, untreated malignant pericardial effusion
- No congestive heart failure
- No other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm ^3
- Creatinine clearance ≥ 40 mL/min
- Creatinine ≤ 1.8 mg/dL
- Bilirubin < 1.5 mg/dL
- SGOT ≤ 2 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Males or females of reproductive potential may not participate unless they have agreed to use effective barrier contraceptive methods
- No prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy is not allowed
- At least three weeks since prior radiotherapy and recovered from all toxicities
- At least three weeks must have elapsed from major surgery and recovered from all adverse effects of surgery
- No prior colony-stimulating factors or interferon
No concurrent hormonal, biologic, or radiotherapy to measurable lesions
- Patients may receive concurrent palliative radiotherapy to small-field nonmeasurable sites of disease (e.g., painful bony metastases)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Time to treatment failure
|
Progression-free survival
|
Overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of response (complete response and partial response)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julie Brahmer, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- JHOC-J0428, CDR0000450843
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-J0428
- BMS-JHOC-J0428
- JHOC-BRAAN-21048
- MSGCC-0060
- JHOC-04112308
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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