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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00408694 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, 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 bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: bevacizumab Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer |
| Estimated Enrollment: | 46 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
Stage IIB-IVB disease
PATIENT CHARACTERISTICS:
Urine protein:creatinine (UPC) ratio < 1.0
No severe, active comorbidity, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
No prior systemic chemotherapy for the study cancer
Contacts and Locations
Show 96 Study Locations| Principal Investigator: | Nancy Lee, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00408694 History of Changes |
| Other Study ID Numbers: | CDR0000518526, RTOG-0615 |
| Study First Received: | December 6, 2006 |
| Last Updated: | February 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx |
|
Head and Neck Neoplasms Nasopharyngeal Neoplasms Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Bevacizumab Cisplatin Fluorouracil Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |