Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276588
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : August 9, 2010
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Phase 2

Detailed Description:



  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : March 2007

Primary Outcome Measures :
  1. Overall survival
  2. Progression-free survival
  3. Time to treatment failure
  4. Time to progression

Secondary Outcome Measures :
  1. Duration of response (complete response and partial response)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276588

Layout table for location information
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Julie Brahmer, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results:
Layout table for additonal information Identifier: NCT00276588     History of Changes
Other Study ID Numbers: JHOC-J0428, CDR0000450843
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
adenocarcinoma of the lung
adenosquamous cell lung cancer
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs