NCT00023712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2001

Completed
2 months until next milestone

Study Start

First participant enrolled

November 5, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

8.2 years

First QC Date

September 13, 2001

Results QC Date

September 17, 2013

Last Update Submit

July 22, 2019

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (3)

  • Tumor Response Duration

    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.

    From study entry, up to 5 years

  • Frequency and Severity of Observed Adverse Events

    Up to 5 years

  • Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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.

    From study entry until disease progression/intolerable toxicity/study withdrawal

Secondary Outcomes (2)

  • Overall Survival

    From study entry, up to 5 years following disease progression

  • Progression-Free Survival

    From study entry up to 5 years

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

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

Drug: bortezomibOther: laboratory biomarker analysisOther: pharmacological study

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (bortezomib)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Melissa Leventhal
Organization
Gynecologic Oncology Group(GOG) Statistical and Data Center
mleventhal@gogstats.org
716-845-4030

Study Officials

  • Carol Aghajanian

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

November 5, 2001

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 30, 2019

Results First Posted

November 20, 2013

Record last verified: 2019-07

Locations

US(1)