Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

AGO Study Group

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: pegylated liposomal doxorubicin hydrochloride; Drug: carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00032162

AGOSG-AGO-GYN-2

EU-20147

CDR0000069262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

63 participants in 1 patient group

PLD

Experimental group

Description:

dose finding study of PLD in combination with Carboplatin

Treatment:

Drug: pegylated liposomal doxorubicin hydrochloride

Drug: carboplatin