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

NCT ID: NCT00276588

Last Updated: 2010-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

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 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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Principal Investigators

Julie Brahmer, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Bridges BB, Thomas L, Hausner PF, Doyle LA, Bedor M, Smith R, Brahmer J, Edelman MJ. Phase II trial of gemcitabine/carboplatin followed by 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. Lung Cancer. 2008 Jul;61(1):61-6. doi: 10.1016/j.lungcan.2007.11.009. Epub 2008 Jan 16.

Reference Type: RESULT

PMID: 18201795 (View on PubMed)

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0428

Identifier Type: -

Identifier Source: secondary_id

BMS-JHOC-J0428

Identifier Type: -

Identifier Source: secondary_id

JHOC-BRAAN-21048

Identifier Type: -

Identifier Source: secondary_id

MSGCC-0060

Identifier Type: -

Identifier Source: secondary_id

JHOC-04112308

Identifier Type: -

Identifier Source: secondary_id

JHOC-J0428, CDR0000450843

Identifier Type: -

Identifier Source: org_study_id