NCT00004139

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Sep 1999

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

8 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

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

May 25, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

December 10, 1999

Last Update Submit

July 19, 2016

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancersquamous cell lung cancerlarge cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lungbronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • response rate

    Up to 2 years

  • overall survival

    Up to 2 years

  • failure-free survival

    Up to 2 years

Study Arms (2)

Gemcitabine + Irinotecan

EXPERIMENTAL
Drug: gemcitabine hydrochlorideDrug: irinotecan hydrochloride

Gemcitabine + Docetaxel

EXPERIMENTAL
Drug: docetaxelDrug: gemcitabine hydrochloride

Interventions

docetaxelDRUG
Gemcitabine + Docetaxel
gemcitabine hydrochlorideDRUG
Gemcitabine + DocetaxelGemcitabine + Irinotecan
irinotecan hydrochlorideDRUG
Gemcitabine + Irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB, IV, or recurrent non-small cell lung cancer (NSCLC) including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Stage IIIB eligible for other CALGB protocols consisting of combined chemotherapy and chest radiotherapy not permitted Malignant pleural effusion allowed CNS metastases allowed following completion of cranial radiotherapy Unidimensionally or bidimensionally measurable disease Solid tumor mass or hilar lesion surrounded by aerated lung Pleural based mass Mediastinal or hilar adenopathy clearly measurable No bone only disease No pleural or pericardial effusions No irradiated lesions unless progression is documented following radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN if SGOT is greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix or breast Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy At least 2 weeks since prior whole brain radiotherapy or stereotactic radiotherapy for CNS disease Surgery: At least 2 weeks since prior surgery for CNS disease

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

Sponsors & Collaborators

Study Sites (8)

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (2)

  • Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE 2nd, Crawford J, Govindan R, King GW, Green MR; Cancer Leukemia Group B. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol. 2004 Mar;15(3):410-8. doi: 10.1093/annonc/mdh104.

    PMID: 14998842RESULT

  • Rocha Lima CM, Rizvi NA, Zhang K, et al.: CALGB 39809: Randomized phase II trial of gemcitabine/irinotecan and gemcitabine/docetaxel in stage IIIB (malignant pleural effusion) or stage IV NSCLC. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1344, 2002.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

DocetaxelGemcitabineIrinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloids

Study Officials

  • Caio Max S. Rocha Lima, MD

    Medical University of South Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 25, 2004

Study Start

September 1, 1999

Primary Completion

July 1, 2004

Study Completion

January 1, 2006

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

US(8)