NCT00183742

Brief Summary

This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called Doxil), when given together and to determine the side effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease the size of several different tumors. Taxotere is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for the treatment of ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_1 cancer

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

December 1, 2000

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

4.8 years

First QC Date

September 9, 2005

Last Update Submit

May 20, 2014

Conditions

CancerCarcinoma

Keywords

Phase 1Phase IPhase oneSolid tumor

Outcome Measures

Primary Outcomes (2)

  • To determine the maximum tolerated dose (MTD) of liposomal doxorubicin (Doxil) administered every 4 weeks or every 2 weeks in combination with docetaxel (Taxotere) administered on a weekly schedule

  • To establish the toxicity profile of this combination

Interventions

liposomal doxorubicin and docetaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • Histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available.
  • Ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (CA) 125 of \> 100 are eligible.
  • SWOG performance status 0-2.
  • Absolute granulocyte count (AGC) greater than or equal to 1.5; platelets greater than or equal to 100,000.
  • Total bilirubin less than or equal to the upper limit of normal (ULN).
  • Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is \<= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are \<= ULN. However, patients who have both transaminase elevation \> 1.5 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity).
  • Age greater than or equal to 18 years.
  • Fully recovered from acute toxicities from chemotherapy, radiation, or surgery.
  • Negative serum pregnancy test, if patient is female, still fertile, and sexually active.

You may not qualify if:

  • Prior treatment with Doxil or weekly docetaxel. Prior docetaxel administered every 3 weeks is allowed.
  • Evidence of moderate peripheral neuropathy greater than or equal to grade 2.
  • Medical, social, or psychological factors interfering with compliance.
  • Known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with Doxil in the opinion of the investigator.
  • Cardiac ejection fraction \< 50%
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma

Interventions

liposomal doxorubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Syma Iqbal, M.D.

    U.S.C./Norris Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

December 1, 2000

Primary Completion

October 1, 2005

Study Completion

May 1, 2006

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)