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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00588770 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, 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. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works with or without bevacizumab in treating patients with recurrent or metastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: bevacizumab Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: fluorouracil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab In Patients With Recurrent Or Metastatic Head and Neck Cancer |
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: cisplatin
Given IV
Drug: docetaxel
Given IV
|
|
Experimental: Arm II
Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously over days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
|
|
Experimental: Arm III
Patients receive carboplatin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
|
|
Experimental: Arm IV
Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: carboplatin
Given IV
Drug: fluorouracil
Given IV
|
|
Experimental: Arm V
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: cisplatin
Given IV
Drug: docetaxel
Given IV
|
|
Experimental: Arm VI
Patients receive chemotherapy as in arm II and bevacizumab as in arm V. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
|
|
Experimental: Arm VII
Patients receive chemotherapy as in arm III and bevacizumab as in arm V. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
|
|
Experimental: Arm VIII
Patients receive chemotherapy as in arm IV and bevacizumab as in arm V. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: fluorouracil
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by performance status (0 vs 1), weight loss (< 5% vs ≥ 5% of total body weight in the past 6 months), prior radiotherapy to head and neck (yes vs no), and chemotherapy regimen (cisplatin/docetaxel vs carboplatin/docetaxel vs cisplatin/fluorouracil vs carboplatin/fluorouracil). Patients are randomized to 1 of 8 treatment arms.
In all arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.*
NOTE: *Treatment with chemotherapy may be discontinued if there is maximum response (i.e., no improvement in tumor measurements for 2 or more courses) after course 6; bevacizumab administration continues until disease progression in arm II.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) from any primary site, including unknown primary cancers of the head and neck
Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
Patients must have measurable disease based on RECIST
Patients must be progression-free for at least 6 months after completion of chemotherapy or chemoradiotherapy or radiotherapy plus cetuximab given as part of initial potential curative therapy (if received such prior therapy)
PATIENT CHARACTERISTICS:
AST or ALT and alkaline phosphatase must meet one of the following criteria:
Patients who meet the following criteria are excluded:
Patients with a prior history of squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated
Patients must have a blood pressure (BP) ≤ 150/90 within 2 weeks prior to randomization
PRIOR CONCURRENT THERAPY:
No more than one prior radiotherapy regimen, curative or palliative, to the head and neck allowed
No prior chemotherapy or biologic/molecular-targeted therapy for recurrent or metastatic SCCHN
Patients may have received one regimen of induction, concurrent chemoradiotherapy, and/or adjuvant chemotherapy as part of initial potential curative therapy
Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function
Contacts and Locations
Show 421 Study Locations| Study Chair: | Athanassios Argiris, MD | University of Pittsburgh |
| Investigator: | Panos Savvides, MD | Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00588770 History of Changes |
| Other Study ID Numbers: | CDR0000582533, ECOG-E1305 |
| Study First Received: | December 28, 2007 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Unspecified |
|
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary |
untreated metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer tongue cancer |
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Docetaxel Bevacizumab 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 Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |