Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

NCT ID: NCT00032162

Last Updated: 2012-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

Conditions

Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLD

dose finding study of PLD in combination with Carboplatin

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

AUC 6 q4w

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

20/30/40 mg/qm q4w Dose finding study

Interventions

carboplatin

AUC 6 q4w

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

20/30/40 mg/qm q4w Dose finding study

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AGO Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas du Bois, MD, PhD

Role: STUDY_CHAIR

Dr. Horst-Schmidt-Kliniken

Locations

Universitaetsklinikum Charite

Berlin, , Germany

Zentralkrankenhaus

Bremen, , Germany

Medizinische Klinik I

Dresden, , Germany

Universitaetsklinik Duesseldorf

Düsseldorf, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Staedtisches Krankenhaus FFM-Hoechst

Frankfurt am Main, , Germany

Universitaetsklinik Goettingen

Göttingen, , Germany

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, , Germany

Frauenklinik der MHH

Hanover, , Germany

Vincentius Krankenhaus

Karlsruhe, , Germany

Christian-Albrechts University of Kiel

Kiel, , Germany

Klinik der Otto - v. - Guericke - Universitat

Magdeburg, , Germany

Klinikum Grosshadern

Munich (Muenchen), , Germany

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich (Muenchen), , Germany

Klinik und Poliklinik fuer Kinderheilkunde

Münster, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Universitaet Ulm

Ulm, , Germany

Dr. Hors t- Schmidt - Kliniken

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 17910981 (View on PubMed)

Other Identifiers

AGOSG-AGO-GYN-2

Identifier Type: -

Identifier Source: secondary_id

EU-20147

Identifier Type: -

Identifier Source: secondary_id

CDR0000069262

Identifier Type: -

Identifier Source: org_study_id