Clinical trial · Interventional
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
NCT00023712CI-TRIAL-00039800completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (3)
- measure
- Tumor Response Duration
- timeFrame
- From study entry, up to 5 years
- description
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.