Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032162
• Other study ID #: CDR0000069262
• Secondary ID: AGOSG-AGO-GYN-2E
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2002
• Last updated: May 29, 2012
• Start date: August 2001

Study information

• Verified date: May 2012
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Sarcoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• carboplatin
AUC 6 q4w
• pegylated liposomal doxorubicin hydrochloride
20/30/40 mg/qm q4w Dose finding study

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Charite	Berlin
Germany	Zentralkrankenhaus	Bremen
Germany	Medizinische Klinik I	Dresden
Germany	Universitaetsklinik Duesseldorf	Duesseldorf
Germany	Evangelisches Krankenhaus	Dusseldorf
Germany	Klinikum der J.W. Goethe Universitaet	Frankfurt
Germany	Staedtisches Krankenhaus FFM-Hoechst	Frankfurt Am Main
Germany	Universitaetsklinik Goettingen	Gottingen
Germany	Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet	Greifswald
Germany	Frauenklinik der MHH	Hannover
Germany	Vincentius Krankenhaus	Karlsruhe
Germany	Christian-Albrechts University of Kiel	Kiel
Germany	Klinik der Otto - v. - Guericke - Universitat	Magdeburg
Germany	Klinik und Poliklinik fuer Kinderheilkunde	Muenster
Germany	Klinikum Grosshadern	Munich (Muenchen)
Germany	Klinikum Rechts Der Isar/Technische Universitaet Muenchen	Munich (Muenchen)
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitaet Ulm	Ulm
Germany	Dr. Hors t- Schmidt - Kliniken	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
AGO Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

du Bois A, Pfisterer J, Burchardi N, Loibl S, Huober J, Wimberger P, Burges A, Stähle A, Jackisch C, Kölbl H; Arbeitsgemeinschaft Gynäekologische Onkologie Studiengruppe Ovarialkarzinom; Kommission Uterus. Combination therapy with pegylated liposomal doxo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DL DLT		DLT during first 3 cycles	Yes