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Lenalidomide and Paclitaxel in Prostate Cancer

NCT00933426 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-10-26

No results posted yet for this study

Summary

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes.

The goal of the Phase II part of this clinical research study is to learn if lenalidomide and paclitaxel can help to control prostate cancer.

The safety of this combination treatment will be studied in both phases of the study.

UPDATE:

Study was terminated early due to slow accrual as a Phase I dose escalation study, without progression to Phase II study portion.

Conditions

Interventions

DRUG

Lenalidomide

Lead-In beginning dose of 5 mg capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28) for a 28 day cycle.

DRUG

Paclitaxel

50 mg/m\^2 given by vein over 1 hour on Days 1, 8, and 15 of each 28 day cycle.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lance Pagliaro, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00933426 on ClinicalTrials.gov