NCT00003037

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 I/II trial to study the effectiveness of combination chemotherapy with docetaxel, gemcitabine, and cisplatin as induction therapy in treating patients with stage III non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1997

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

November 25, 2003

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

4.9 years

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Interventions

cisplatinDRUG
docetaxelDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed Stage III (T1-2 N2-3 M0, T3 N2 M0, or T4 N0-3 M0) non-small cell lung cancer Must be candidates for either a resection with curative intent or definitive thoracic irradiation following induction chemotherapy No malignant pericardial or pleural effusions or superior vena cava syndrome Must have measurable or evaluable indicator lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL SGOT and/or SGPT no greater than 1.5 times the upper limit of normal Alkaline phosphatase no greater than 5 times the upper limit of normal Renal: Creatinine clearance at least 65 mL/min Cardiovascular: Must have stable heart rhythm No unstable angina No myocardial infarction within 6 months No clinical evidence of congestive heart failure Neurologic: Must have normal auditory function No symptoms of peripheral neuropathy Other: No prior malignancy except non-melanoma skin cancer or in situ carcinoma of the cervix Not pregnant Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CisplatinDocetaxelGemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jorge Gomez, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

November 25, 2003

Study Start

April 1, 1997

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

US(1)