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

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.

Key facts

Study ID

NCT00090610

Run by

Duke University

People needed

150

Starts

2003-10-01

Expected to finish

2009-10-01

Last updated by the study team

2015-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida Gynecologic Oncology — Fort Myers, Florida, United States
• Jupiter Medical Center-Gynecology Oncology and Gynecology — Jupiter, Florida, United States
• Florida Hospital/Gyn/Onc Department — Orlando, Florida, United States
• Hematology-Onc. Assoc. of The Quad Cities — Bettendorf, Iowa, United States
• University of Iowa — Iowa City, Iowa, United States
• Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology — Baltimore, Maryland, United States
• Cancer Center at Hackensack — Hackensack, New Jersey, United States
• Columbia University College of Physicians and Surg — New York, New York, United States
• Hope: A Woman's Cancer Center — Asheville, North Carolina, United States
• University of North Carolina/ Division of Gyn Oncology — Chapel Hill, North Carolina, United States
• Carolinas Medical Center/Gyn Oncology Department — Charlotte, North Carolina, United States
• Duke University/Division of Gynecologic Oncology — Durham, North Carolina, United States
• Forsyth Regional Cancer Center — Winston-Salem, North Carolina, United States
• Gynecologic Oncology and Surgery — Oklahoma City, Oklahoma, United States
• PA Hematology/Oncology Associates — Philadelphia, Pennsylvania, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• MUSC-Div of Gyn/Oncology — Charleston, South Carolina, United States
• The West Cancer Clinic — Memphis, Tennessee, United States
• Southwest Regional Cancer Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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