Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

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)