Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer

• Status: Withdrawn
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.

PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simmons Cancer Center; University of Texas Southwestern Medical Center
• Collaborator: Ortho Biotech Clinical Affairs, L.L.C.
• Treatments: Carboplatin; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian carcinoma

• Recurrent disease

• Known platinum-sensitive recurrent disease after no more than 2 prior salvage regimens

• Measurable disease as defined by a target lesion and a CA125 level

• No epithelial ovarian carcinoma of low malignant potential

PATIENT CHARACTERISTICS:

Inclusion criteria:

• GOG performance status 0, 1, or 2

• Life expectancy > 6 months

• Absolute neutrophil count ≥ 1,500/uL

• Platelet count ≥ 100,000/uL

• Hemoglobin > 9.0 g/dL

• Creatinine ≤ 2.0 mg/dL

• Bilirubin ≤ 1.5 x upper limit of normal (ULN)

• SGOT and alkaline phosphatase ≤ 3 x ULN

• Neuropathy (sensory and motor) ≤ CTCAE grade 1

Exclusion criteria:

• GOG performance status 3 or 4

• Pregnant or breastfeeding

• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®

• Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)

• Septicemia or severe infection

• Acute hepatitis or severe gastrointestinal bleeding

• Any of the following:

• Unstable angina

• Myocardial infarction within the past 6 months

• NYHA class II-IV heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmias

• Clinically significant pericardial disease

• Electrocardiographic evidence of acute ischemic or active conduction system abnormalities

• Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months

• Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

• At least 6 months since prior adjuvant regimen

• At least 4 weeks since prior salvage treatment

• May have received secondary cytoreduction for recurrent ovarian cancer

• May have received prior intraperitoneal therapy for ovarian cancer

• May have received no more than 2 prior platinum and taxane-based regimens

• May have received prior intraperitoneal platinum during front-line treatment

Exclusion criteria:

• Prior anthracycline dose exceeding 360 mg/m^2 for doxorubicin hydrochloride (including DOXIL®) or 720 mg/m^2 for epirubicin hydrochloride

• Prior radiotherapy

• Prior intraperitoneal carboplatin or cisplatin as salvage treatment for recurrent ovarian cancer

• Concurrent amifostine or other protective agents