NCT00005806

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 trial to study the effectiveness of combination chemotherapy in treating patients who have advanced 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 Sep 1999

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
1.7 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
2.4 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

June 2, 2000

Last Update Submit

June 17, 2013

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

carboplatinDRUG
gefitinibDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed advanced or metastatic non-small cell lung cancer considered incurable with standard surgery or irradiation No active brain metastases as indicated by clinical symptoms, cerebral edema, and/or progressive growth PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 that has not worsened within the past 7 days Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases) Renal: Creatinine no greater than 1.25 times ULN No greater than a trace of blood or protein on urine labstix test Cardiovascular: No prior history of clinically significant cardiac dysrhythmia, first degree heart block, or other severe cardiac disease Opthalmologic: No potentially visually threatening epithelial abnormality of the cornea other than scars, congenital abnormality, or corneal tear film (e.g., neurotrophic keratitis, corneal edema, or recurrent erosions) No signs and symptoms of keratoconjunctivitis sicca No concurrent use of contact lenses Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancies within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No evidence of severe or uncontrolled systemic diseases (e.g., hepatitis B, hepatitis C, or HIV) No known chronic conditions No active dermatoses involving the face No evidence of any other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell lung cancer No concurrent biologic response modifiers Concurrent filgrastim (G-CSF) allowed only for persistent neutropenia despite dose reductions in prior course Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: No concurrent hormonal therapy No concurrent tamoxifen Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Recovered from prior oncologic or other major surgery Other: No other concurrent anticancer therapy No other concurrent investigational agents No concurrent drugs with known significant 3A4 inhibitory effects (i.e., ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) No concurrent hydroxychloroquine, amiodarone, or chlorpromazine No concurrent topical eye medication

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

CarboplatinGefitinibPaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Vincent A. Miller, 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

June 2, 2000

First Posted

July 19, 2004

Study Start

September 1, 1999

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)