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CompletedNCT00276588Updated Aug 9, 2010

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

A Phase 2 interventional study of carboplatin and gemcitabine hydrochloride in Lung Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-09.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • 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
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 46 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 72 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 67 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
46 participants (estimated)
06

What researchers measure

Primary outcomes

  1. Overall survival

  2. Progression-free survival

  3. Time to treatment failure

  4. Time to progression

Secondary outcomes

  1. Duration of response (complete response and partial response)

07

Study locations

2 sites
  • Greenebaum Cancer Center at University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
08

References and documents

Publications

  • 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. PubMed 18201795 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2005 and a primary completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2006
First posted
Jan 13, 2006
Start
Jul 2005
Primary completionActual
Mar 2007
Last update
Aug 9, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00276588
First posted
Jan 13, 2006
Start date
Jul 2005
Primary completion
Mar 2007
Last update
Aug 9, 2010

Study contacts

Julie Brahmer, MD
principal investigator · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Carboplatin · Gemcitabine · Paclitaxel

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