NCT00093626

Brief Summary

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

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

Study Start

First participant enrolled

October 1, 2004

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

October 6, 2004

Last Update Submit

July 22, 2019

Conditions

Primary Peritoneal CarcinomaRecurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of adverse events as assessed by CTCAE v3.0

    Up to 5 years

  • Progression-free survival

    Will be evaluated using proportional hazards modeling and Fisher's exact test.

    6 months

Secondary Outcomes (4)

  • Duration of overall survival

    Up to 5 years

  • Duration of progression-free survival

    Up to 5 years

  • Frequency of clinical response (complete and partial response) defined by RECIST criteria

    Up to 5 years

  • Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type])

    Up to 5 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Sorafenib Tosylate

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (sorafenib tosylate)
Sorafenib TosylateDRUG

Given orally

Also known as: BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib
Treatment (sorafenib tosylate)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Persistent or recurrent disease
  • Measurable or evaluable disease
  • Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
  • Evaluable disease is defined as at least 1 of the following:
  • CA 125 ≥ 2 times upper limit of normal (ULN)
  • Ascites and/or pleural effusion attributed to tumor
  • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions
  • Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound
  • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Platinum-resistant according to 1 of the following criteria:
  • Treatment-free interval of \< 12 months after platinum therapy
  • Disease progression during platinum-based therapy
  • Persistent disease after a platinum-based regimen
  • Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
  • +52 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

Ovarian Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Daniela Matei

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

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

October 6, 2004

First Posted

October 8, 2004

Study Start

October 1, 2004

Primary Completion

September 1, 2007

Study Completion

January 1, 2011

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

US(1)