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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00276588
First received: January 12, 2006
Last updated: August 5, 2010
Last verified: August 2010

January 12, 2006
August 5, 2010
July 2005
March 2007   (final data collection date for primary outcome measure)
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00276588 on ClinicalTrials.gov Archive Site
Duration of response (complete response and partial response) [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
Not Provided
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. Epub 2008 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Not Provided
March 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276588
JHOC-J0428, CDR0000450843, P30CA006973, JHOC-J0428, BMS-JHOC-J0428, JHOC-BRAAN-21048, MSGCC-0060, JHOC-04112308
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Julie Brahmer, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP