Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer

The University of Texas System (UT)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: carboplatin

Drug: doxorubicin hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00562185

CDR0000574034

ORTHO-SCCC-04E07

SCCC-062007-043

SCCC-04E07

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
To evaluate the feasibility of this regimen in these patients.

Secondary

To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.

OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.

Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.

After completion of study treatment, patients are followed every 4 weeks for 1 year.

PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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