Clinical trial NCT00023712: Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official title: A Phase II Evaluation of Bortezomib (Velcade™, PS-341, NSC #681239, IND #58443) in the Treatment of Persistent or Recurrent Platinum-Sensitive Epithelial Ovarian or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Gynecologic Oncology Group
First posted: 2003-01-27
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Tumor Response Duration
timeFrame: From study entry, up to 5 years
measure: Frequency and Severity of Observed Adverse Events
timeFrame: Up to 5 years
measure: Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
timeFrame: From study entry until disease progression/intolerable toxicity/study withdrawal
Secondary outcomes:
measure: Overall Survival
timeFrame: From study entry, up to 5 years following disease progression
measure: Progression-Free Survival
timeFrame: From study entry up to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Carol Aghajanian
role: PRINCIPAL_INVESTIGATOR
References: