Phase II Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Stage II Lymphoepithelioma of the Nasopharynx 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 |
Drug: docetaxel Drug: cisplatin Drug: carboplatin Drug: fluorouracil Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC) |
- Progression free survival rate, using RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]Estimated according to the methods of Kaplan and Meier.
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Estimated according to the methods of Kaplan and Meier.
- Rates of adverse events resulting in treatment discontinuation [ Time Frame: Up to 1 month after completion of study treatment ] [ Designated as safety issue: Yes ]The rates of AEs resulting in protocol treatment discontinuation will be estimated using a binomial distribution along with their associated 95% confidence intervals. Only adverse events assessed as definitely, probably, or possibly related to protocol treatment will be considered.
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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. |
Drug: docetaxel
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: fluorouracil
Given IV
Other Names:
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Other Names:
Radiation: intensity-modulated radiation therapy
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Other Name: IMRT
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Alexander D. Colevas 650-724-9707 colevas@stanford.edu | |
| Principal Investigator: Alexander D. Colevas | |
| Principal Investigator: | Alexander Colevas | Stanford University |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00896181 History of Changes |
| Obsolete Identifiers: | NCT00841997 |
| Other Study ID Numbers: | NCI-2009-01162, ENT0025 |
| Study First Received: | May 7, 2009 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
Docetaxel Cisplatin Fluorouracil Carboplatin 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 |
ClinicalTrials.gov processed this record on May 19, 2013