NCT00102414

Brief Summary

The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
356

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline
Completed

Started Sep 1999

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

September 1, 1999

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2005

Completed
Last Updated

November 14, 2006

Status Verified

January 1, 2005

First QC Date

January 29, 2005

Last Update Submit

November 13, 2006

Conditions

Ovarian Cancer

Keywords

Ovarian cancerRecurrence or progressionGemcitabine plus Carboplatin vs Carboplatin

Outcome Measures

Primary Outcomes (1)

  • Time to progressive disease

Secondary Outcomes (5)

  • Response rate

  • Duration of response

  • Survival time

  • Toxicity

  • Quality of Life

Interventions

GemcitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically proven ovarian cancer with evidence of recurrence or progression
  • Failed first-line platinum containing therapy after 6 months of treatment discontinuation
  • Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
  • Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
  • Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10\^9/L and platelets ≥ 100 x 10\^9/L

You may not qualify if:

  • Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
  • Clinical evidence of central nervous system metastases
  • Active infection
  • Cannot adequately be followed up for the duration of the study
  • A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Serious concomitant systematic disorders incompatible with the study
  • Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
  • Patients with tumor of borderline malignancy
  • Patients with estimated GFR ≤ 50 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Luck HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. doi: 10.1200/JCO.2006.06.0913. Epub 2006 Sep 11.

    PMID: 16966687RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrenceDisease Progression

Interventions

Gemcitabine

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 DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jacobus Pfisterer, Prof. Dr. med.

    AGO Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2005

First Posted

January 31, 2005

Study Start

September 1, 1999

Study Completion

November 1, 2004

Last Updated

November 14, 2006

Record last verified: 2005-01