Doxil Topotecan Doublet Cancer Study

NCT00252889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-01-27

No results posted yet for this study

Summary

The primary objective is to determine the nature and degree of the toxicity of weekly dosing of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed dose of pegylated liposomal doxorubicin (Doxil).

The secondary objective is to determine the activity of weekly topotecan and pegylated liposomal doxorubicin in advanced solid tumors.

Conditions

Interventions

DRUG

Topotecan and pegylated doxorubicin

Doxil 40 mg/m2 day 1 and topotecan was to be escalated in cohorts of patients

Sponsors & Collaborators

Principal Investigators

  • Michael J. Guarino, M.D. · Christiana Care Health Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-03-31
Completion
2008-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252889 on ClinicalTrials.gov