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

NCT01158248 | Unknown Phase 2

• 4 other identifiers: CDR0000675699MUI-AGO-20EUDRACT-2009-012453-38EU-21043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

Interventions

panitumumab BIOLOGICAL

cisplatin DRUG

brachytherapy RADIATION

external beam radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Panitumumab; Cisplatin; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Officials

• Alain Zeimet

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Last Updated: July 9, 2010

Record last verified: 2010-07

Locations

AU (1)