Trial record 14 of 15 for:    Open Studies | "Carcinoma, Small Cell"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01158248
First received: July 7, 2010
Last updated: July 8, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Biological: panitumumab
Drug: cisplatin
Radiation: brachytherapy
Radiation: external beam radiation therapy
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 4 months by MRI according to RECIST criteria [ Designated as safety issue: No ]
  • Rate of skin and/or gastrointestinal toxicity CTCAE grade 4 at 4 months [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate at 4 months according to RECIST criteria [ Designated as safety issue: No ]
  • Progression-free survival at 12 and 24 months according to RECIST criteria [ Designated as safety issue: No ]
  • Overall survival at 12 and 24 months [ Designated as safety issue: No ]
  • Rate of severe adverse events according to CTCAE at 4 months [ Designated as safety issue: Yes ]
  • Rate of post-treatment severe adverse events according to CTCAE at 12 and 24 months [ Designated as safety issue: Yes ]
  • Rate of severe adverse events according to CTCAE of panitumumab monotherapy at day 14 [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158248

Locations
Austria
Innsbruck Universitaetsklinik Recruiting
Innsbruck, Austria, A-6020
Contact: Contact Person    43-512-504-24155    Alain.zeimet@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Alain Zeimet Medical University Innsbruck
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01158248     History of Changes
Other Study ID Numbers: CDR0000675699, MUI-AGO-20, EUDRACT-2009-012453-38, EU-21043
Study First Received: July 7, 2010
Last Updated: July 8, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014