Clinical trial NCT00032162: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: AGO Study Group
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DL DLT
timeFrame: DLT during first 3 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite
city: Bremen
country: Germany
facility: Zentralkrankenhaus
city: Dresden
country: Germany
facility: Medizinische Klinik I
city: Duesseldorf
country: Germany
facility: Universitaetsklinik Duesseldorf
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Frankfurt Am Main
country: Germany
facility: Staedtisches Krankenhaus FFM-Hoechst
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universitaet
city: Gottingen
country: Germany
facility: Universitaetsklinik Goettingen
city: Greifswald
country: Germany
facility: Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
city: Hannover
country: Germany
facility: Frauenklinik der MHH
city: Karlsruhe
country: Germany
facility: Vincentius Krankenhaus
city: Kiel
country: Germany
facility: Christian-Albrechts University of Kiel
city: Magdeburg
country: Germany
facility: Klinik der Otto - v. - Guericke - Universitat
city: Muenster
country: Germany
facility: Klinik und Poliklinik fuer Kinderheilkunde
city: Munich (Muenchen)
country: Germany
facility: Klinikum Grosshadern
city: Munich (Muenchen)
country: Germany
facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitaet Ulm
city: Wiesbaden
country: Germany
facility: Dr. Hors t- Schmidt - Kliniken
Study officials:
affiliation: Dr. Horst-Schmidt-Kliniken
name: Andreas du Bois, MD, PhD
role: STUDY_CHAIR
References:
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.