Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 11/23/2018 |
| Start Date: | January 2009 |
| End Date: | July 2020 |
A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
This phase II trial is studying whether giving a combination of docetaxel, cisplatin, and
fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy
works in treating patients with advanced nasopharyngeal cancer. 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. 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 radiation therapy may kill
more tumor cells.
fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy
works in treating patients with advanced nasopharyngeal cancer. 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. 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 radiation therapy may kill
more tumor cells.
PRIMARY OBJECTIVE:
I. To establish the progression free survival rate at 2 years, using RECIST criteria, to
induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by
chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)
SECONDARY OBJECTIVE:
I. To evaluate complete response rates, safety and feasibility of TPF followed by
chemoradiation in patients with NPC
OUTLINE: This is a single site study.
INDUCTION THERAPY: Patients receive docetaxel IV over 60 minutes on day 1; cisplatin IV over
1-3 hours (or carboplatin IV over 30 minutes) on day 1; and fluorouracil IV continuously over
24 hours on days 1-5. Treatment repeats every 21 days for up to 3 courses in the absence of
disease progression or unacceptable toxicity.
CONCURRENT CHEMORADIOTHERAPY: Beginning within 3-6 weeks after initiating the last course of
induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated
radiotherapy once daily for 6.5-7 weeks. Patients also receive cisplatin IV over 1 hour (or
carboplatin IV over 30 minutes) once weekly in weeks 1-6 in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
I. To establish the progression free survival rate at 2 years, using RECIST criteria, to
induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by
chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)
SECONDARY OBJECTIVE:
I. To evaluate complete response rates, safety and feasibility of TPF followed by
chemoradiation in patients with NPC
OUTLINE: This is a single site study.
INDUCTION THERAPY: Patients receive docetaxel IV over 60 minutes on day 1; cisplatin IV over
1-3 hours (or carboplatin IV over 30 minutes) on day 1; and fluorouracil IV continuously over
24 hours on days 1-5. Treatment repeats every 21 days for up to 3 courses in the absence of
disease progression or unacceptable toxicity.
CONCURRENT CHEMORADIOTHERAPY: Beginning within 3-6 weeks after initiating the last course of
induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated
radiotherapy once daily for 6.5-7 weeks. Patients also receive cisplatin IV over 1 hour (or
carboplatin IV over 30 minutes) once weekly in weeks 1-6 in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
Inclusion Criteria:
- Histologically or cytologically confirmed nasopharyngeal carcinoma meeting the
following criteria:
- WHO type I, II, or III
- Stage II -IVB disease (minimally T2a, N0, M0 or any T any, 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
- ECOG performance status 0-1
- Life expectancy > 3 months
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- 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
- Not pregnant or nursing
- Fertile patients must use effective contraception prior to and during study treatment
- Hearing loss < grade 2. Hearing loss grade 2 or greater attributable to tumor
obstruction, when the bone conduction in the audiogram is consistent with less than
grade 2, is permissible for cisplatin. Hearing loss will be evaluated by hearing in
the best ear. If hearing loss is grade 2, patients are still eligible but should
receive carboplatin throughout the protocol instead of cisplatin.
- Peripheral motor/sensory neuropathy < grade 2. If peripheral neuropathy is grade 2,
patients are still eligible but should receive carboplatin throughout the protocol
instead of cisplatin.
- No uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that preclude compliance with study
requirements
- No clinically significant cardiovascular disease
- 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 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
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
We found this trial at
1
site
900 Quarry Road Extension
Stanford, California 94305
Stanford, California 94305
(650) 723-5111
Principal Investigator: Alexander D. Colevas
Phone: 650-736-1598
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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