NCT00004159

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 gemcitabine plus paclitaxel in treating patients who have advanced non-small cell lung cancer or other solid tumor.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Feb 2000

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 10, 1999

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2000

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

November 20, 2013

Status Verified

March 1, 2013

Enrollment Period

Same day

First QC Date

December 10, 1999

Last Update Submit

November 18, 2013

Conditions

Lung Cancer

Keywords

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

Interventions

gemcitabine hydrochlorideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Phase I portion (closed for accrual after the maximum tolerated dose and dose limiting toxicity were determined) Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) or other solid tumor for which no standard curative treatment exists Phase II portion (open for accrual): Histologically proven stage IV NSCLC without prior chemotherapy Measurable or evaluable disease No primary brain tumors Brain metastases allowed if controlled by radiation or stereotactic radiosurgery No lymphoproliferative disease No HIV related malignancies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No serious nonmalignant disease No active/uncontrolled infection or bleeding (e.g., active peptic ulcer disease) No other primary malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No allergy to Cremophor PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Phase I: No prior paclitaxel or gemcitabine At least 3 weeks since other prior chemotherapy and recovered Phase II: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered 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)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

GemcitabinePaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Francisco Robert, MD, FACP

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

July 26, 2004

Study Start

February 1, 2000

Primary Completion

February 1, 2000

Study Completion

February 1, 2000

Last Updated

November 20, 2013

Record last verified: 2013-03

Locations

US(1)