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DX-8951f in Treating Patients With Metastatic Stomach Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as DX-8951f in Treating Patients With Metastatic Stomach Cancer. DX-8951f in Treating Patients With Metastatic Stomach Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a DX-8951f in Treating Patients With Metastatic Stomach Cancer clinical trial. Subjects often receive the most expert healthcare possible for their DX-8951f in Treating Patients With Metastatic Stomach Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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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 3 Gastric Cancer Studies:
1. Biological Therapy in Treating Patients With Advanced Cancer
2. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
3. Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
4. DX-8951f in Treating Patients With Metastatic Stomach Cancer
5. Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
Related Studies:
Other stage 3 gastric cancer Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
DX-8951f in Treating Patients With Metastatic Stomach Cancer
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