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Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

NCT00657878 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2023-11-13

No results posted yet for this study

Summary

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Conditions

Interventions

DRUG

stealth liposomal doxorubicin

stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days

DRUG

carboplatin

carboplatin AUC 5 IV day 1 every 21 days

DRUG

paclitaxel

paclitaxel 175 mg/m2 IV day 1 every 21 days

DRUG

Topotecan

dosing and schedule according to Institutional guidelines

DRUG

Gemcitabine

1000 mg/m2 on days 1,8,15 every 28 days

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, M.D., Ph.D. · National Cancer Institute, Naples

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

  • Marilina Piccirillo, M.D. · National Cancer Institute, Naples

  • Ciro Gallo, M.D., Ph.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Belgium
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657878 on ClinicalTrials.gov