|
DX-8951f in Treating Patients With Metastatic Stomach Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on DX-8951f in Treating Patients With Metastatic Stomach Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. DX-8951f in Treating Patients With Metastatic Stomach Cancer Clinical research trials and DX-8951f in Treating Patients With Metastatic Stomach Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including DX-8951f in Treating Patients With Metastatic Stomach Cancer. DX-8951f in Treating Patients With Metastatic Stomach Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a DX-8951f in Treating Patients With Metastatic Stomach Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their DX-8951f in Treating Patients With Metastatic Stomach Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > DX-8951f in Treating Patients With Metastatic Stomach Cancer  DX-8951f in Treating Patients With Metastatic Stomach Cancer
DX-8951f in Treating Patients With Metastatic Stomach Cancer
For Condition: stage 4 gastric cancer,adenocarcinoma of the stomach,stage 3 esophageal cancer,recurrent esophageal cancer,stage 3 gastric cancer,recurrent gastric cancer,Adenocarcinoma of the Esophagus,stage 4 esophageal cancer
Status: Suspended
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.
Details: OBJECTIVES: - Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate (DX-8951f). - Determine the time to tumor progression in this patient population when treated with this drug. - Determine the survival at 6 and 12 months in this patient population when treated with this drug. - Determine the quantitative and qualitative toxic effects of this drug in this patient population. - Determine the pharmacokinetics of this drug in the plasma of these patients. OUTLINE: This is a multicenter study. Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed gastric or gastroesophageal adenocarcinoma - Lymph node involvement and/or distant metastasis - No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach - Measurable disease with indicator lesions outside the field of prior radiotherapy - At least 20 mm by conventional scan OR - At least 10 mm by spiral CT scan - Nonmeasurable lesions include the following: - Primary tumor - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Cystic lesions - Abdominal masses not confirmed and followed by imaging techniques - No prior treatment for locally advanced or metastatic disease - Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - Albumin at least 2.8 g/dL - PT or INR no greater than 1.5 times ULN (coumadin independent) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No active congestive heart failure - No uncontrolled angina - No myocardial infarction within the past 6 months Other: - No concurrent serious infection - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No overt psychosis, mental disability, or incompetence that would preclude informed consent - No other life-threatening illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - No concurrent anti-cancer biologic therapy - No concurrent prophylactic colony stimulating factors during first course of therapy Chemotherapy: - Recovered from prior adjuvant chemotherapy - No other concurrent anti-cancer chemotherapy - No other concurrent anti-cancer cytotoxic therapy Endocrine therapy: - Concurrent megestrol for appetite stimulation allowed Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No prior wide-field radiotherapy to more than 25% of bone marrow - No concurrent anti-cancer radiotherapy Surgery: - At least 4 weeks since prior major surgery and recovered - No concurrent anti-cancer surgery Other: - No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Pacific Shores Medical Group
Long Beach, California, 90813
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229-3264
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Additional Information:
Study ID Numbers: CDR0000068663; DAIICHI-8951A-PRT028,UTHSC-0015011134,SACI-IDD-00-27
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017212
Other Stage 4 Esophageal Cancer Studies:
1. Irinotecan in Treating Patients With Advanced Cancer of the Stomach
2. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
3. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
4. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
5. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
Related Studies:
Other stage 4 esophageal cancer Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
DX-8951f in Treating Patients With Metastatic Stomach Cancer
|
|
|
|
|
|
|
|
