NCT00276588

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

January 12, 2006

Last Update Submit

August 5, 2010

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lungadenosquamous cell lung cancerlarge cell lung cancerrecurrent non-small cell lung cancersquamous cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (4)

  • Overall survival

  • Progression-free survival

  • Time to treatment failure

  • Time to progression

Secondary Outcomes (1)

  • Duration of response (complete response and partial response)

Interventions

carboplatinDRUG
gemcitabine hydrochlorideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • 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.

    PMID: 18201795RESULT

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of LungCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinGemcitabinePaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Julie Brahmer, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

July 1, 2005

Primary Completion

March 1, 2007

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(2)