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| ID | Type | Description | Link |
|---|---|---|---|
| MUI-AGO-20 | |||
| EUDRACT-2009-012453-38 | |||
| EU-21043 |
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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
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological | |||
| cisplatin | Drug | |||
| brachytherapy | Radiation | |||
| external beam radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed cervical cancer, including the following subtypes:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Zeimet | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck Universitaetsklinik | Recruiting | Innsbruck | A-6020 | Austria |
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| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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