Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

May 29, 2012 updated by: AGO Study Group

Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors.
  • Determine the dose-limiting toxicity of this regimen in these patients.
  • Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.

Patients are followed at 4-6 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-10117
        • Universitaetsklinikum Charite
      • Bremen, Germany, D-28205
        • Zentralkrankenhaus
      • Dresden, Germany, D-01307
        • Medizinische Klinik I
      • Duesseldorf, Germany, D-40225
        • Universitaetsklinik Duesseldorf
      • Dusseldorf, Germany, DOH-40217
        • Evangelisches Krankenhaus
      • Frankfurt, Germany, 60596
        • Klinikum der J.W. Goethe Universitaet
      • Frankfurt Am Main, Germany, 65929
        • Staedtisches Krankenhaus FFM-Hoechst
      • Gottingen, Germany, D-37075
        • Universitaetsklinik Goettingen
      • Greifswald, Germany, D-17487
        • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
      • Hannover, Germany, 30659
        • Frauenklinik der MHH
      • Karlsruhe, Germany, D-76137
        • Vincentius Krankenhaus
      • Kiel, Germany, D-24105
        • Christian-Albrechts University of Kiel
      • Magdeburg, Germany, 39108
        • Klinik der Otto - v. - Guericke - Universitat
      • Muenster, Germany, D-48129
        • Klinik und Poliklinik fuer Kinderheilkunde
      • Munich (Muenchen), Germany, D-81377
        • Klinikum Großhadern
      • Munich (Muenchen), Germany, D-81675
        • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
      • Tuebingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, D-89075
        • Universitaet Ulm
      • Wiesbaden, Germany, D-65199
        • Dr. Hors t- Schmidt - Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer

    • No ovarian epithelial cancer

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin greater than 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal

Renal:

  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • No atrial or ventricular arrhythmias
  • No congestive heart failure even if stabilized on medication
  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within the past 6 months

Other:

  • No pre-existing sensory or motor neuropathy grade 2 or greater
  • No active infection
  • No other serious medical condition that would preclude study
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • No more than 1 prior chemotherapy regimen for the malignancy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal therapy within the past 10 days allowed
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow

Surgery:

  • Not specified

Other:

  • At least 30 days since prior experimental agents
  • No other concurrent therapies that would preclude study
  • No concurrent participation in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PLD
dose finding study of PLD in combination with Carboplatin
Drug: carboplatin
AUC 6 q4w
Drug: pegylated liposomal doxorubicin hydrochloride
20/30/40 mg/qm q4w Dose finding study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DL DLT
Time Frame: DLT during first 3 cycles
DLT during first 3 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069262
  • AGOSG-AGO-GYN-2
  • EU-20147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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