Clinical trial NCT01158248: Panitumumab, Cisplatin, and Pelvic Radiation Therapy in Treating Patients With Stage IB, Stage II, or Stage III Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
cervical squamous cell carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-07-08
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival at 4 months by MRI according to RECIST criteria
measure: Rate of skin and/or gastrointestinal toxicity CTCAE grade 4 at 4 months
Secondary outcomes:
measure: Overall response rate at 4 months according to RECIST criteria
measure: Progression-free survival at 12 and 24 months according to RECIST criteria
measure: Overall survival at 12 and 24 months
measure: Rate of severe adverse events according to CTCAE at 4 months
measure: Rate of post-treatment severe adverse events according to CTCAE at 12 and 24 months
measure: Rate of severe adverse events according to CTCAE of panitumumab monotherapy at day 14
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
Study officials:
affiliation: Medical University Innsbruck
name: Alain Zeimet
role: PRINCIPAL_INVESTIGATOR
References: