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OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer Clinical research trials and OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer. OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer  OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: A treatment cycle will include intravenous cisplatin (75 mg/m2 every 3 weeks), intravenous docetaxel (60 mg/m2 every 3 weeks), and oral OSI-774 (100 mg daily). Docetaxel at 60 mg/m2 will be administered over a 1 hour intravenous infusion followed by cisplatin at 75 mg/m2 over a 30-minute infusion. Docetaxel and cisplatin treatments will be repeated every 21 days. OSI-774 will be administered orally on Day 1 at 100 mg dose. Patients may experience a dose escalation of 150 mg, pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
Details: A treatment cycle will include intravenous cisplatin (75 mg/m2 every 3 weeks), intravenous docetaxel (60 mg/m2 every 3 weeks), and oral OSI-774 (100 mg daily). Docetaxel at 60 mg/m2 will be administered over a 1 hour intravenous infusion followed by cisplatin at 75 mg/m2 over a 30-minute infusion. Docetaxel and cisplatin treatments will be repeated every 21 days. OSI-774 will be administered orally on Day 1 at 100 mg dose. Patients may experience a dose escalation of 150 mg, pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
Eligibility:
Study Type: Interventional,燭reatment,燦on-Randomized,燨pen Label,燯ncontrolled,燬ingle Group Assignment,燬afety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx. - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. - Patients who have not received any prior systemic chemotherapy for metastatic or recurrent head and neck squamous cell carcinoma. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months. - Age >18 years. - No acute intercurrent illness or infection. - ECOG performance status <2. - Patients must have normal organ and marrow function defined as: 路 leukocytes >= 3,000/mL 路 absolute neutrophil count >= 1,500/mL 路 platelets >= 100,000/mL 路 hemoglobin >= 8g/dL 路 total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)<= 2.5 X institutional upper limit of normal if alkaline phosphatase is < ULN OR Alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN 路 creatinine within normal institutional limits OR creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the completion of therapy. - Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria - Patients who have had chemotherapy or radiotherapy for their recurrent or metastatic head and neck cancer. - Patients may not be receiving any other investigational agents. - Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study. - Patient has received prior biologic therapy targeting EGFR. - Patient has signs or symptoms of acute infection requiring systemic therapy. - Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient鈥檚 understanding of the informed consent. - Patient requires total parenteral nutrition with lipids. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Histology other than squamous cell carcinoma. - Patients refusing to sign the informed consent. - Patients with a history of severe hypersensitivity reaction to Taxotere庐. - Patients with pre-existing peripheral neuropathy NCI CTC grade 2 or worse. - Pregnant or lactating women are excluded from this study because OSI-774 is an unknown Class agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774. These potential risks may also apply to other agents used in this study. - Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774, cisplatin, or docetaxel or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. - Inclusion of women and minorities. Both men and women and members of all ethnic groups are eligible for this trial. The proposed study population will consist of patients of all ethnic backgrounds and either gender, treated at MD Anderson Cancer Center Houston, Texas.
Total Enrollment: 50
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Barbara Burke 713-745-6779
Additional Information:
Study ID Numbers: ID02-668;
Study Start Date: January 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076310
Other Head And Neck Cancer Studies:
1. Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
2. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
3. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
4. Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
5. Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
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OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
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