Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

In brief

Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Key facts

Study ID

NCT00023712

Run by

National Cancer Institute (NCI)

People needed

58

Starts

2001-11-05

Expected to finish

2010-01-01

Last updated by the study team

2019-07-30

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
• Measurable disease
• At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan, or MRI) OR at least 10 mm by spiral CT scan
• Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen for primary disease (e.g., carboplatin, cisplatin, or other organoplatinum compound)
• A second regimen containing paclitaxel allowed provided patient received no prior paclitaxel therapy
• Platinum-sensitive disease
• Treatment-free interval without progressive disease for more than 6 months but less than 12 months after therapy with platinum-based regimen
• At least 1 target lesion outside previously irradiated field
• Ineligible for higher priority GOG protocol
• Performance status - GOG 0-2 (if received 1 prior therapy regimen)
• Performance status - GOG 0-1 (if received 2 prior therapy regimens)
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No evidence of acute ischemia or significant conduction abnormality (e.g., left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular block) on electrocardiogram
• No myocardial infarction within the past 6 months
• No cerebrovascular event or transient ischemic attack within the past 6 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancy within the past 5 years except non-melanoma skin cancer

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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