Head & Neck Cancer Treatment Trials
Progression-free survival with XL184 as compared with placebo in subjects with medullary thyroid cancer (SLHN 2008-32; Exelexis XL 184-301)
Purpose
The purpose of this research study is to evaluate the progression-free survival (PFS, period after last dose of drug, while cancer is said to be stable) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable (unable to be completely removed through surgery), advanced stage, or metastatic (spreading) medullary thyroid cancer (MTC). Subjects will be assigned to their drug at random to receive XL184 or placebo in a 2:1 ratio. XL184 works by altering proteins needed for tumor formation and growth.
Eligibility Criteria
-
Confirmed diagnosis of MTC that cannot be removed by surgery, is in an advanced stage, or has spread in the body.
-
At least 18 years old.
-
Documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening.
-
Recovered from clinically significant adverse events (side effects) due to any other medications that were administered prior to patient assignment of the study drug.
-
The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed 2 years or greater previously).
-
No prior treatment for their cancer within 4 to 6 weeks of assignment to their study drug.
-
The subject has not received radiation to 25% or greater of bone marrow.
-
No spread of cancer to the brain.
Final eligibility will be determined by the research staff.
Erlotinib Hydrochloride with Docetaxel and Radiotherapy in patients with advanced stage head and neck cancer (SLHN 2007-100; CASE 5307)
Purpose
The purpose of this study is to determine how well the combination of erlotinib hydrochloride works with docetaxel, and radiotherapy in patients with advanced stage head and neck cancer.
Entry Criteria
- Confirmed squamous cell carcinoma of the head and neck of either stage III or IV, with no distant metastatic (spreading) disease
- Disease that can be measured by an X-ray of scan
- No salivary gland or sinus cancer
- No known spread of cancer to the brain
- No prior chemotherapy, radiotherapy, investigational anti-tumor drug, or other investigational agents.
Phase II/III Randomized Study of Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine Hydrochloride in Head and Neck Cancer Patients With Early Radiotherapy-Induced Xerostomia (RTOG 0537)
Purpose
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- More than three months since finishing radiation therapy with or without chemotherapy
- At least two weeks since pilocarpine
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Some patients will undergo a 20-minute ALTENS treatment twice a week for 12 weeks.
Other patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive pilocarpine by mouth three times-a-day for 12 weeks.
- Patients in group two will undergo a 20-minute ALTENS treatment twice-a-week for 12 weeks.
Patients in both groups will fill out quality-of-life questionnaires periodically. After finishing treatment, patients will be evaluated at three months.
Phase III Randomized Study of Cisplatin-Containing Chemotherapy With Versus Without Bevacizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (ECOG 1305)
Purpose
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. 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.
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.
Eligibility
Eligibility criteria include the following
- At least 18 years old
- Disease that can be measured on an X-ray or scan
- No spread of cancer to the brain
- No previous chemotherapy or biological therapy for recurrent or metastatic cancer
- At least 6 months since chemotherapy or chemotherapy with radiation therapy for this cancer
- No previous bevacizumab
- More than 4 weeks since surgery or open biopsy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive a 1-hour infusion of docetaxel and a 1- to 2-hour infusion of cisplatin on day 1, or a 1- to 2-hour infusion of cisplatin on day 1 and a 4-day continuous infusion of fluorouracil beginning on day 1. Treatment may repeat every 3 weeks for at least six courses.
- Patients in group two will receive a 1-hour infusion of docetaxel and a 1- to 2-hour infusion of cisplatin on day 1, or a 1- to 2-hour infusion of cisplatin on day 1 and a 4-day continuous infusion of fluorouracil beginning on day 1. They will also receive a 30- to 90-minute infusion of bevacizumab on day 1. Treatment may repeat every 3 weeks for at least six courses. Treatment with bevacizumab alone may continue every 3 weeks for as long as benefit is shown.
After finishing treatment, patients will be evaluated every three to six months for five years.