Andrew Quon
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, and Radiation Therapy in Treating Patients With Advanced Nasopharyngeal Carcinoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving combination chemotherapy together with bevacizumab and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with bevacizumab and radiation therapy works in treating patients with advanced nasopharyngeal cancer.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: bevacizumab
- Drug: docetaxel
- Drug: cisplatin
- Drug: 5-Fluorouraci
- Procedure: Chemoradiation
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed nasopharyngeal carcinoma meeting the following criteria:
o WHO type I, II, or III
o Stage II -IVB disease (minimally T2a, N0, M0 or any T, N1, M0)
- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan
- Prior diagnostic surgery(s) at the primary site or neck allowed provided there is still measurable disease present
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 3 months
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- INR <= 1.5 times upper limit of normal (ULN)
- aPTT <= 1.5 times ULN
- Total bilirubin <= 1.5 times ULN
- AST and ALT <= 2.5 times ULN
- Creatinine <= 1.5 mg/dL or creatinine clearance >= 55 mL/min- NOTE: * Patients with creatinine > grade 1 but < grade 3, hearing loss >= grade 2, and peripheral neuropathy >= grade 2 are eligible provided they receive carboplatin in place of cisplatin throughout study treatment
- Urine protein:creatinine ratio < 1.0 or 24-hour urine protein < 1,000 mg
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during study treatment
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
o Ongoing or active infection
o Symptomatic congestive heart failure
o Unstable angina pectoris
o Cardiac arrhythmia
o Psychiatric illness or social situations that preclude compliance with study requirements
- No clinically significant cardiovascular disease
- No inadequately controlled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg despite antihypertensive medication
- No cerebrovascular accident within the past 6 months
- No myocardial infarction or unstable angina within the past 6 months
- No NYHA class II-IV congestive heart failure
- No serious and inadequately controlled cardiac arrhythmia
- No significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)
- No clinically significant peripheral vascular disease
- No gross bleeding from any site within the past 4 weeks
o Clinically insignificant non-arterial mucosal bleeding from the nasopharyngeal carcinoma primary site allowed
- No traumatic injury within the past 4 weeks
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to docetaxel, cisplatin, carboplatin, fluorouracil, bevacizumab, or other agents used in this study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
- No prior bevacizumab or other agents specifically targeting VEGF
- More than 4 weeks since prior major surgical procedures
- More than 15 days since prior incisional or excisional surgical biopsies for nasopharyngeal carcinoma
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent full-dose anticoagulants (i.e., warfarin or heparin) allowed provided the following criteria are met:
o No active bleeding or pathological condition that carries a high risk of bleeding
o Stable dose of anticoagulation (if on warfarin, INR should be stable in the therapeutic range)
- No concurrent primary prophylactic administration of filgrastim (G-CSF) or sargramostim (GM-CSF) during course one of induction therapy
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)Anticipated start date:
12/10/2008Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Complete response rate
Secondary Outcomes:
- Duration of response, Progression-free survival
Total Number to be Enrolled:
40Total Number to be Enrolled at Stanford:
9More Information
Secondary ID(s):
- ENT0025
- NCT00841997
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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