NCT00081276

Brief Summary

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 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

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

April 7, 2004

Last Update Submit

January 23, 2013

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

  • Frequency and duration of objective response assessed using RECIST criteria

    Up to 5 years

  • Frequency and severity of observed adverse effects assessed using CTCAE version 3.0

    Up to 5 years

Secondary Outcomes (3)

  • Duration of progression-free survival

    From study entry until disease recurrence, death or date of last contact, assessed up to 5 years

  • Duration of overall survival

    From study entry to death or date of last contact, assessed up to 5 years

  • Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)

    Up to 5 years

Study Arms (1)

Treatment (triapine and cisplatin)

EXPERIMENTAL

Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: triapineDrug: cisplatinOther: laboratory biomarker analysis

Interventions

triapineDRUG

Given IV

Also known as: 3-AP, OCX-191
Treatment (triapine and cisplatin)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (triapine and cisplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (triapine and cisplatin)

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 cancer
  • Recurrent or persistent disease
  • At least 1 unidimensionally measurable target lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Outside a previously irradiated field
  • Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
  • Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment
  • Considered platinum resistant or refractory, according to 1 of the following criteria:
  • Treatment-free interval of less than 6 months after platinum-based therapy
  • Disease progression during platinum-based therapy
  • Ineligible for any higher priority GOG protocol
  • Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
  • Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • Kunos C, Radivoyevitch T, Abdul-Karim FW, Fanning J, Abulafia O, Bonebrake AJ, Usha L. Ribonucleotide reductase inhibition restores platinum-sensitivity in platinum-resistant ovarian cancer: a Gynecologic Oncology Group Study. J Transl Med. 2012 Apr 27;10:79. doi: 10.1186/1479-5876-10-79.

    PMID: 22541066DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazoneCisplatin

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)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Lydia Usha

    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

April 7, 2004

First Posted

April 8, 2004

Study Start

July 1, 2005

Primary Completion

January 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)