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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Overall survival
Progression-free survival
Time to treatment failure
Time to progression

Secondary Outcome Measures

Duration of response (complete response and partial response)

Full Information

First Posted
January 12, 2006
Last Updated
August 5, 2010
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276588
Brief Title
Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Overall survival
Title
Progression-free survival
Title
Time to treatment failure
Title
Time to progression
Secondary Outcome Measure Information:
Title
Duration of response (complete response and partial response)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Brahmer, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18201795
Citation
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.
Results Reference
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Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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