NCT00005872

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent 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 May 1999

Typical duration for phase_2 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2004

Completed
Last Updated

December 4, 2013

Status Verified

September 1, 2001

First QC Date

June 2, 2000

Last Update Submit

December 3, 2013

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer

Interventions

rubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy 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 2.0 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled serious medical or psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major surgery

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

Sponsors & Collaborators

Study Sites (1)

SuperGen, Incorporated

Dublin, California, 94568, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

rubitecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Show-Li Sun, MD

    Astex Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2000

First Posted

April 12, 2004

Study Start

May 1, 1999

Study Completion

April 1, 2004

Last Updated

December 4, 2013

Record last verified: 2001-09

Locations

US(1)