Panitumumab, Cisplatin, and Pelvic Radiation Therapy in Treating Patients With Stage IB, Stage II, or Stage III Cervical Cancer
Recruitment status was: Recruiting
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving panitumumab and cisplatin together with pelvic radiation therapy may be effective in treating patients with cervical cancer.
PURPOSE: This phase II trial is studying the side effects of giving panitumumab and cisplatin together with pelvic radiation therapy in treating patients with stage IB, stage II, or stage III cervical cancer.
|Cervical Cancer||Biological: panitumumab Drug: cisplatin Radiation: brachytherapy Radiation: external beam radiation therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Two-Stage Multicenter Phase II Trial of Concurrent Panitumumab Immunotherapy, Cisplatin Chemotherapy and Pelvic Radiotherapy for Primary Cancer of the Uterine Cervix Stage IB-IIIB|
- Progression-free survival at 4 months by MRI according to RECIST criteria
- Rate of skin and/or gastrointestinal toxicity CTCAE grade 4 at 4 months
- Overall response rate at 4 months according to RECIST criteria
- Progression-free survival at 12 and 24 months according to RECIST criteria
- Overall survival at 12 and 24 months
- Rate of severe adverse events according to CTCAE at 4 months
- Rate of post-treatment severe adverse events according to CTCAE at 12 and 24 months
- Rate of severe adverse events according to CTCAE of panitumumab monotherapy at day 14
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- To assess the activity of concurrent panitumumab and cisplatin chemoradiotherapy in patients with stage IB-IIIB, KRAS-wild type (KRAS^wt) cervical cancer, in terms of progression-free survival at 4 months by MRI according to RECIST criteria.
- To assess the rate of skin toxicity (e.g., photosensitivity, acneiform rash, and dermatitis) CTCAE grade 4 and/or gastrointestinal toxicity (comprising all grades of gastrointestinal perforation; leakage of stomach, small intestine, colon, rectum, or elsewhere in the peritoneal cavity occurring after the first application of study treatment and not immediately related to a surgical procedure) at 4 months, of this regimen in these patients.
- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of overall response rate at 4 months.
- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of progression-free survival at 12 months and 24 months.
- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of overall survival at 12 months and 24 months.
- To assess the rate of severe adverse events of this regimen in patients with KRAS^wt and KRAS-mutant gene status at 4 months.
- To assess the rate of post-treatment severe adverse events at 12 months and 24 months.
- To assess the rate of severe adverse events of panitumumab monotherapy at day 14.
OUTLINE: This is a multicenter study.
Patients receive panitumumab IV on days 1, 14, 29, and 43 and cisplatin IV on days 14, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. Patients undergo concurrent external-beam and intracavitary radiotherapy (teletherapy of pelvis or high-dose rate brachytherapy) according to treating center specific standards.
Blood and tissue specimens are collected periodically for laboratory analysis.
After completion of study treatment, patients are followed periodically for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158248
|Innsbruck, Austria, A-6020|
|Contact: Contact Person 43-512-504-24155 Alain.firstname.lastname@example.org|
|Principal Investigator:||Alain Zeimet||Medical University Innsbruck|