NCT00193570

Brief Summary

This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_1 cancer

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

February 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 23, 2009

Status Verified

January 1, 2009

Enrollment Period

2.5 years

First QC Date

September 12, 2005

Last Update Submit

January 22, 2009

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine maximum tolerated dose of drug combination

Secondary Outcomes (1)

  • Response rates

Interventions

TopotecanDRUG
DocetaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Adult \> 18 years of age
  • ECOG performance status 0 or 1
  • Received 3 or less chemotherapy regimens in the metastatic setting
  • Adequate bone marrow, liver and kidney function
  • Prior brain metastases must be inactive and asymptomatic
  • No previous treatment with Topotecan or docetaxel
  • Understand the nature of the study and give written informed consent

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Moderate or severe peripheral neuropathy
  • Active concurrent infection or serious underlying medical condition
  • Known HIV positivity
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

TopotecanDocetaxel

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Howard A. Burris, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2002

Primary Completion

August 1, 2004

Study Completion

January 1, 2009

Last Updated

January 23, 2009

Record last verified: 2009-01