Phase 2
N=46
Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 · Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 · Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 · Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 · Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT00408694 ↗Enrolled (actual)
46
Serious AEs
63.6%
Results posted
Apr 2013
Primary outcome: Primary: Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Bevacizumab (Biological); Cisplatin (Drug); Fluorouracil (Drug); Intensity-Modulated Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. |
— | — |
| SECONDARY Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year. |
— | — |
| SECONDARY Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen |
68.2; 68.2 | — |
| SECONDARY Death During or Within 30 Days of Discontinuation of Protocol Treatment. |
— | — |
| SECONDARY One- and Two-year Distant Metastases-free Rates |
97.7; 90.8 | — |
| SECONDARY One- and Two-year Loco-regional Progression-free Rates |
93.2; 74.7 | — |
| SECONDARY One- and Two-year Progression-free Survival Rates |
90.9; 74.7 | — |
| SECONDARY One- and Two-year Overall Survival Rates |
93.2; 90.9 | — |
| SECONDARY Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment |
90.9 | — |
Summary
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. 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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
- Histologic WHO types I-IIb/III
- Stage IIB-IVB disease
- No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
- No distant metastases
- Zubrod performance status 0-1
- WBC ? 4,000/mm?
- Hemoglobin ? 9.0 g/dL
- Platelet count ? 100,000/mm?
- Absolute neutrophil count ? 1,500/mm?
- INR ? 1.5
- aPTT ? 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ? 1.5 times ULN
- ALT and AST ? 1.5 times ULN
- Bilirubin ? 1.5 times ULN
- Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
- Urine protein: creatinine (UPC) ratio 0.5, 24-hour urine protein must be 15% from baseline)
- History of arterial thromboembolic events
- Acquired immune deficiency syndrome
- Transmural myocardial infarction
- Cerebrovascular accident
- Transient ischemic attack
- Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance
- No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
- Nutritional and physical condition considered suitable for study treatment
- No significant traumatic injury within the past 4 weeks
- No history of allergic reaction to the study drugs
- No baseline blood pressure > 150/100 mm Hg
- No peripheral neuropathy ? grade 2
- Not pregnant or nursing
- Negative serum pregnancy test
- Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
- At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
- No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
- More than 15 days since prior biopsies
- More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
- More than 4 weeks since prior major surgical procedures
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- No prior bevacizumab or other vascular endothelial growth factor-targeting agents
- No prior systemic chemotherapy for the study cancer
- Prior chemotherapy for a different cancer allowed
- No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
- No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
- No concurrent prophylactic amifostine or pilocarpine
- No other concurrent experimental therapeutic cancer treatments
Data sourced from ClinicalTrials.gov (NCT00408694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.