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A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery Clinical research trials and A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery clinical trial. Participants oftentimes recieve the finest healthcare available for their A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery  A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
For Condition: Rectal Neoplasms,Stomach Neoplasms
Status: Terminated
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. , Ortho Biotech
Synopsis: The primary objective of the study is to demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery. Secondary objectives include the following: (1) to evaluate the efficacy of epoetin alfa in maintaining hemoglobin levels during preoperative chemoradiation, (2) to evaluate the effect of epoetin alfa on quality of life (QoL) as measured by patient self-reported Linear Analog Scale Assessment (LASA), Functional Assessment of Cancer Therapy – Anemia (FACT-An), and the Brief Fatigue Inventory (BFI) and (3) to evaluate tumor response. Safety of epoetin alfa treatment will also be assessed.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Patients must be male or female 18 years of age or older - Patients must have a histologically confirmed diagnosis of gastric cancer or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery. - Patients must have a baseline hemoglobin value of > 10 g/dL and < 15 g/dL. - Patients must have adequate hematologic function defined as ANC >=1500/mm3, and platelet count >=100,000/mm3. (Must be unrelated to transfusion within the past 30 days) - Patients must have a life expectancy of > 6 months. - Karnofsky performance status must be > 50%.(Attachment 4) - Patients must have adequate renal function (serum creatinine <=1.5) and adequate hepatic function (serum bilirubin <=2.0, SGPT <=3 times the upper limit normal). - Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment. - Patients must have signed an Informed Consent form after the nature of the study has been fully explained and all questions have been answered to the patient's satisfaction. - Patients must be able to read, understand and complete the three Quality of Life (QoL) tools (FACT-An, LASA and BFI) in the language in which they have all been validated (English). EXCLUSION CRITERIA Patients who meet any of the following criteria will be excluded from participating in the study: - Prior chemotherapy for patients with rectal cancer. - Gastric cancer patients who have received more than two cycles of chemotherapy. - Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate deficiencies, hemolysis or gastrointestinal bleeding). - Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin, novel erythropoiesis stimulating protein) within the previous six months. - Patients with known hypersensitivity to mammalian-cell derived products or to human albumin. - Pregnant or lactating women. - Patients with untreated CNS metastases. - Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy. - Uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis. - New onset (within 3 months prior to randomization) or poorly controlled seizures. - History of active second malignancy. (Except for basal cell carcinoma in situ) - Major infection requiring hospitalization and antibiotics within 14 days of randomization. - Major surgery within 14 days of randomization. - Transfusion of white blood cells or packed red blood cells within one month prior to randomization. - Administration of androgen therapy within 2 months of randomization. - Employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of the investigator or study center.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: PR00-03-006;
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036400
Other Stomach Neoplasms Studies:
1. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
2. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
3. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
4. Phase II Study of Single Agent OSI-7904L in patients with Gastric or Gastroesophageal (GEJ) Cancer
5. Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
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A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
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