Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetax... | NCT00183742

Studies
Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)

NCT00183742

Sponsor

University of Southern California

Status

Completed

Last Update Posted

May 22, 2014Estimated

Enrollment

Phase

Phase 1

Conditions

Cancer
Carcinoma

Interventions

liposomal doxorubicin and docetaxel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2000

Primary Completion Date

Oct 2005Actual

Completion Date

May 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 22, 2014Estimated

Name	Class
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
liposomal doxorubicin and docetaxel	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009369	Neoplasms
D002277	Carcinoma

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

ID	Term
C506643	liposomal doxorubicin
D000077143	Docetaxel