NCT00316433

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

April 18, 2006

Last Update Submit

April 4, 2007

Conditions

Small Cell Lung Cancer

Interventions

Irinotecan (CPT-11)DRUG
Oxaliplatin (Eloxatin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated extensive small cell lung cancer
  • No prior chemotherapy
  • No prior radiotherapy except for the treatment of brain metastases

You may not qualify if:

  • Prior treatment for extensive stage small cell lung cancer
  • Known hypersensitivity to any of the components of oxaliplatin or CPT-11
  • Greater than grade 2 peripheral neuropathy
  • Known HIV or Hepatitis B or C (active, previously treated or both)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

IrinotecanOxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Howard (Jack) West, MD

    Swedish Medical Center Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

February 1, 2005

Study Completion

January 1, 2007

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

US(1)