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A Phase II Evaluation of PS-341 (NSC# 681239) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Phase 2
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase II Evaluation of PS-341 (NSC# 681239) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer


I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent
platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.

II. Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria:

- 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

- No sensory or motor neuropathy greater than grade 1

- No more than 1 prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines,
or small-molecule inhibitors of signal transduction) for recurrent or persistent

- At least 4 weeks since prior biological or immunological agents and recovered

- No prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial chemotherapy regimen

- At least 4 weeks since prior chemotherapy and recovered

- At least 1 week since prior anti-cancer hormonal therapy and recovered

- Concurrent hormone replacement therapy allowed

- At least 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to target lesions

- No prior radiotherapy to more than 25% of marrow-bearing areas

- At least 4 weeks since prior surgery and recovered

- No prior bortezomib

- No prior anti-cancer therapy that would preclude study treatment

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Carol Aghajanian

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103