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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Recurrent Ovarian Epithelial Cancer

Treatments

Drug: bortezomib

Other: pharmacological study

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00023712

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000068853

GOG #0146N (Other Identifier)

GOG-0146N

NCI-2012-02404 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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.

Enrollment

58 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 disease
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