Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Completed · Phase 2

Conditions studied: Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

In brief

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Key facts

Study ID

NCT00093626

Run by

National Cancer Institute (NCI)

People needed

73

Starts

2004-10-01

Expected to finish

2011-01-01

Last updated by the study team

2019-07-23

Who can join

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

You may qualify if…

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
• Persistent or recurrent disease
• Measurable or evaluable disease
• Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
• Evaluable disease is defined as at least 1 of the following:
• CA 125 ≥ 2 times upper limit of normal (ULN)
• Ascites and/or pleural effusion attributed to tumor
• Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions
• Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound
• Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Platinum-resistant according to 1 of the following criteria:
• Treatment-free interval of < 12 months after platinum therapy
• Disease progression during platinum-based therapy
• Persistent disease after a platinum-based regimen
• Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
• No brain metastases
• Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
• Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No known bleeding diathesis
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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