Status:
COMPLETED
Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 d...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00276588
Start Date
July 1 2005
Last Update
August 9 2010
Active Locations (2)
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1
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410