NCT00291837

Brief Summary

The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Nov 2004

Geographic Reach
3 countries

7 active sites

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

November 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

February 14, 2006

Last Update Submit

February 24, 2010

Conditions

Ovarian Cancer

Keywords

ovarianCT-2106

Outcome Measures

Primary Outcomes (1)

  • response rate

Secondary Outcomes (4)

  • toxicity

  • response duration

  • time to progression

  • survival

Interventions

CT-2106DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
  • Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
  • At least one measurable lesion according to RECIST
  • ECOG performance status 0 or 1
  • at least 18 years old
  • Adequate haematological function
  • Adequate renal and hepatic functions
  • Normal coagulation parameters

You may not qualify if:

  • Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months
  • Pregnant or lactating patients
  • Prior treatment with camptothecins
  • Presence or history of CNS metastasis or carcinomatous leptomeningitis;
  • Current active infection per investigator assessment;
  • Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
  • Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
  • Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
  • Other uncontrolled, serious illness or medical condition, as determined by the investigator;
  • Concurrent treatment with any other anti-cancer therapy;
  • Known HIV positivity or AIDS-related illness;
  • Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Lyon, France

Location

Unknown Facility

Saint-Brieuc, France

Location

Unknown Facility

Campobasso, Italy

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Unknown Facility

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

polyglutamate camptothecin

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

Study Officials

  • Hilary Calvert, PhD

    Newcastle General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

November 1, 2004

Primary Completion

June 1, 2006

Study Completion

December 1, 2007

Last Updated

February 26, 2010

Record last verified: 2010-02

Locations

IT(1)GB(4)FR(2)