Overview

Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
Aventis Pharmaceuticals
Treatments:
Carboplatin
Docetaxel
Criteria
Inclusion Criteria:

- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal
carcinoma.

- The patient's tumor is platinum-sensitive, which means that the patient had a complete
response to front-line treatment with a platinum compound and had a treatment-free
interval without clinical evidence of progressive disease for greater than 6 months.

- The patient has received one and only one prior chemotherapy regimen for the treatment
of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is
allowed. Patients who have received consolidation treatment are allowed. Prior
treatment with Taxotere® is not allowed.

o Consolidation therapy is allowed including a different cytotoxic agent than the
agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and
immunotherapy.

- Patients may have received one prior regimen with a biologic therapy, either combined
with cytotoxic therapy in the front-line setting, or as a single-agent for this
recurrence. The biologic therapy must be discontinued at least three weeks prior to
registration.

- Measurable or evaluable disease either by radiologic imaging, or physical exam, or by
measurement of CA125 < 70 on two occasions at least one week apart.

- At least 3 weeks since radiotherapy, with full recovery. The measurable disease must
be completely outside the radiation portal.

- At least 3 weeks since major surgery, with full recovery. Patients who have undergone
a secondary tumor debulking or cytoreductive surgery for this malignancy are excluded.

- Eastern Cooperative Oncology Group (ECOG) performance status < 2.

- Age > 18 years.

- Absolute neutrophil count > 1,500/mm3; platelet count > 100,000/mm3; Hemoglobin > 8.0
g/dl

- Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must
be within the range allowing for eligibility.

- If there is childbearing potential, a serum pregnancy test must be negative.

- Patients of childbearing potential must be willing to consent to using effective
contraception while on treatment and for three months following the completion of
treatment.

- Informed consent has been obtained.

Exclusion Criteria:

- Prior treatment with Taxotere®.

- Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for
the disease. Any hormonal therapy directed at the malignant tumor must be discontinued
at least one week prior to enrollment in order for the patient to be eligible to
participate in this trial. Continuation of Hormone Replacement therapy is permitted.

- Serious concurrent medical or psychiatric illness, including serious active infection.

- Peripheral neuropathy > grade 2.

- History of other malignancy within the last 5 years, except for basal cell skin
carcinoma.

- The patient is pregnant or nursing.

- Patients with a history of severe hypersensitivity reaction to cisplatin, carboplatin,
mannitol, or drugs formulated with Polysorbate 80.

- Secondary debulking for this recurrence.