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T900607 in Treating Patients With Gastroesophageal Junction Cancer



T900607 in Treating Patients With Gastroesophageal Junction Cancer

For Condition: recurrent gastric cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
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 T900607 in treating patients who have gastroesophageal junction cancer.
Details: OBJECTIVES: - Determine the response rate (complete and partial) in patients with previously treated gastric or gastroesophageal junction carcinoma treated with T900607. (Gastric carcinoma temporarily closed to accrual as of 11/17/03.) - Determine the duration of response and time to disease progression in patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. - Determine the safety profile of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed gastric or gastroesophageal junction carcinoma (gastric carcinoma temporarily closed to accrual as of 11/17/03) - Must have received 1 or 2 prior chemotherapy regimens for gastric carcinoma (gastric carcinoma temporarily closed to accrual as of 11/17/03) - Bidimensionally measurable disease - At least 1 lesion that is at least 10 mm by CT scan - No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3* - Platelet count at least 100,000/mm^3* - Hemoglobin at least 8.5 g/dL* NOTE: *Independent of growth factor or transfusion support Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN - INR no greater than 1.5 (unless receiving anticoagulants) - Albumin greater than 2.5 g/dL Renal - Creatinine no greater than 2 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease - LVEF at least 50% - No acute anginal symptoms Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - Able to comply with study procedures and follow-up - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No severe infection - No other concurrent severe medical condition or comorbidity that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - More than 7 days since prior growth factors or blood transfusions - No concurrent therapeutic biological response modifier therapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - No other concurrent cytotoxic chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - No concurrent radiotherapy (including palliative radiotherapy) Surgery - More than 4 weeks since prior major surgery Other - More than 4 weeks since prior investigational agents - No other concurrent investigational anticancer therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JoannaBrell,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-1714
United States
Recruiting Joanna  Brell 216-844-1676


Additional Information:
Study ID Numbers:  CDR0000269917;  CWRU-060214M,TULA-TULI-1202,TULA-T-607-006
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054249

Other Recurrent Gastric Cancer Studies:
1. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

2. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

3. Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

4. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

5. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach

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T900607 in Treating Patients With Gastroesophageal Junction Cancer
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