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Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

NCT01388621 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-08-20

No results posted yet for this study

Summary

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.

Conditions

Interventions

DRUG

Panitumumab

Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.

DRUG

pegylated liposomal doxorubicin (PLD)

pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles

DRUG

Carboplatin

Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles

DRUG

Gemcitabine

gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles

DRUG

Carboplatin

Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles

DRUG

Panitumumab

Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • WiSP Wissenschaftlicher Service Pharma GmbH

    lead OTHER

Principal Investigators

  • Jalid Sehouli, MD (Prof. Dr. med.) · Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-07-31
Completion
2015-07-31

Countries

  • Germany

Study Locations

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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 NCT01388621 on ClinicalTrials.gov