Panitumumab, Cisplatin, and Pelvic Radiation Therapy in Treating Patients With Stage IB, Stage II, or Stage III Cervical Cancer
Panitumumab, Cisplatin, and Pelvic Radiation Therapy in Treating Patients With Stage IB, Stage II, or Stage III Cervical Cancer
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.
OBJECTIVES:

 Primary

 -  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.

 Secondary

 -  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.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed cervical cancer, including the following subtypes:

 -  Squamous small-cell or large-cell carcinoma

 -  Adenosquamous cell carcinoma

 -  Adenocarcinoma

 -  Keratinizing or non-keratinizing carcinoma

 -  Stage IB-IIIB disease

 -  No para-aortic lymph node metastases or clinical indication for para-aortic field
 irradiation

 -  No predominant and clinically effective neuroendocrine tumor cell differentiation

 PATIENT CHARACTERISTICS:

 -  WH0 performance status 0-2

 -  Serum creatinine clearance > 50 mL/min

 -  No other prior or current malignancy within the past 5 years except adequately treated
 nonmelanoma skin cancer or carcinoma in-situ of the cervix

 -  No acute life-threatening vaginal hemorrhage (requiring emergency irradiation or RBC
 transfusion)

 PRIOR CONCURRENT THERAPY:

 -  Not specified