Mode
Text Size
Log in / Sign up
Phase 2 N=58 Treatment

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

Primary Peritoneal Cavity Cancer · Recurrent Ovarian Epithelial Cancer

Enrolled (actual)
58
Serious AEs
20.0%
Results posted
Nov 2013
Primary outcome: Primary: Tumor Response Duration — 3.9; 24.1 months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bortezomib (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)
Age
Pediatric, Adult, Older Adult
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Tumor Response Duration
3.9; 24.1
PRIMARY
Frequency and Severity of Observed Adverse Events
14; 9; 0; 3; 0; 16
PRIMARY
Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
1; 2
SECONDARY
Overall Survival
18.2; 27.2
SECONDARY
Progression-Free Survival
1.5; 1.4

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00023712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search