Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00032162
First received: March 8, 2002
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Sarcoma
Drug: carboplatin
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • DL DLT [ Time Frame: DLT during first 3 cycles ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: August 2001
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032162

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

Additional Information:
Publications:
Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT00032162     History of Changes
Other Study ID Numbers: CDR0000069262, AGOSG-AGO-GYN-2, EU-20147
Study First Received: March 8, 2002
Last Updated: May 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AGO Study Group:
ovarian carcinosarcoma
stage III cervical cancer
recurrent cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IA cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma
fallopian tube cancer
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
ovarian sarcoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Sarcoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014