search
Back to results

Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

Primary Purpose

Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
carboplatin
pegylated liposomal doxorubicin hydrochloride
Sponsored by
AGO Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring 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, ovarian carcinosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaetsklinikum Charite
  • Zentralkrankenhaus
  • Medizinische Klinik I
  • Universitaetsklinik Duesseldorf
  • Evangelisches Krankenhaus
  • Staedtisches Krankenhaus FFM-Hoechst
  • Klinikum der J.W. Goethe Universitaet
  • Universitaetsklinik Goettingen
  • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Frauenklinik der MHH
  • Vincentius Krankenhaus
  • Christian-Albrechts University of Kiel
  • Klinik der Otto - v. - Guericke - Universitat
  • Klinik und Poliklinik fuer Kinderheilkunde
  • Klinikum Grosshadern
  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
  • Universitaetsklinikum Tuebingen
  • Universitaet Ulm
  • Dr. Hors t- Schmidt - Kliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLD

Arm Description

dose finding study of PLD in combination with Carboplatin

Outcomes

Primary Outcome Measures

DL DLT

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
May 29, 2012
Sponsor
AGO Study Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00032162
Brief Title
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Official Title
Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGO Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma
Keywords
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, ovarian carcinosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLD
Arm Type
Experimental
Arm Description
dose finding study of PLD in combination with Carboplatin
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 6 q4w
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Intervention Description
20/30/40 mg/qm q4w Dose finding study
Primary Outcome Measure Information:
Title
DL DLT
Time Frame
DLT during first 3 cycles

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas du Bois, MD, PhD
Organizational Affiliation
Dr. Horst-Schmidt-Kliniken
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinikum Charite
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Zentralkrankenhaus
City
Bremen
ZIP/Postal Code
D-28205
Country
Germany
Facility Name
Medizinische Klinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitaetsklinik Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Dusseldorf
ZIP/Postal Code
DOH-40217
Country
Germany
Facility Name
Staedtisches Krankenhaus FFM-Hoechst
City
Frankfurt Am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitaetsklinik Goettingen
City
Gottingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17487
Country
Germany
Facility Name
Frauenklinik der MHH
City
Hannover
ZIP/Postal Code
30659
Country
Germany
Facility Name
Vincentius Krankenhaus
City
Karlsruhe
ZIP/Postal Code
D-76137
Country
Germany
Facility Name
Christian-Albrechts University of Kiel
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Klinik der Otto - v. - Guericke - Universitat
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Klinik und Poliklinik fuer Kinderheilkunde
City
Muenster
ZIP/Postal Code
D-48129
Country
Germany
Facility Name
Klinikum Grosshadern
City
Munich (Muenchen)
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
City
Munich (Muenchen)
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
Facility Name
Dr. Hors t- Schmidt - Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17910981
Citation
du Bois A, Pfisterer J, Burchardi N, Loibl S, Huober J, Wimberger P, Burges A, Stahle A, Jackisch C, Kolbl H; Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom; Kommission Uterus. Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut). Gynecol Oncol. 2007 Dec;107(3):518-25. doi: 10.1016/j.ygyno.2007.08.008. Epub 2007 Oct 25.
Results Reference
result

Learn more about this trial

Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

We'll reach out to this number within 24 hrs