NCT00193583

Brief Summary

In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started May 2003

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, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months 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
Last Updated

May 4, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

May 3, 2011

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

Secondary Outcomes (2)

  • Dose limiting toxicity

  • All over response

Interventions

TopotecanDRUG
CarboplatinDRUG

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 patients at least 18 years old
  • Advanced solid tumors refractory to conventional therapy
  • ECOG performance status must be 0 or 1
  • Patients may have received no more than 3 prior chemotherapy regimens
  • Adequate bone marrow, liver and kidney function
  • Able to 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:
  • Active concurrent infections or serious underlying medical conditions
  • Known HIV positivity
  • Female patients who are pregnant or lactating
  • Received both topotecan and carboplatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

TopotecanCarboplatin

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

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

May 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2005

Last Updated

May 4, 2011

Record last verified: 2011-05

Locations

US(1)