Mapatumumab, Cisplatin and Radiotherapy for Advanced Cervical Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Advanced Cervical Cancer
Interventions
DRUG

mapatumumab

Mapatumumab (10 or 30 mg/kg) intravenously on days 1, 22, and 45. In phase 2 the MTD established in phase 1 will be used.

DRUG

cisplatin

Cisplatin 40 mg/m2 intravenously on days 8, 15, 22, 29, 36, and 45

RADIATION

radiotherapy

Radiotherapy: a total dose of 45 Gy will be given in fractions of 1.8 Gy, five fractions per week (days 8-12, 15-19, 22-26, 29-33, and 36-40), by external beam irradiation by photon beam of at least 6 MV. After completing the five weeks of external beam irradiation, evaluation will take place to determine whether the boost can be given by brachytherapy. If brachytherapy is not feasible, the boost will be given by external beam irradiation to a total dose of 70.2 Gy in fractions of 1.8 Gy.

Trial Locations (1)

9700 RB

University Medical Center Groningen, Groningen

Sponsors
All Listed Sponsors
collaborator

Human Genome Sciences Inc.

INDUSTRY

lead

University Medical Center Groningen

OTHER