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Home > "S" Clinical Trials Conditions > Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors  Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining soblidotin with gemcitabine in treating patients who have locally advanced or metastaticsolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors. - Determine the dose-limiting toxic effects of this regimen in these patients. Secondary - Determine the toxicity profile of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for survival every 3 months after completion of study therapy. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced or metastatic solid tumors - Minimally pretreated - Not refractory to prior gemcitabine therapy - No disease progression during initial treatment with gemcitabine - No symptomatic 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/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - Ejection fraction at least 40% by MUGA Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric disorder that would preclude study consent or compliance - No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome - No hypersensitivity to gemcitabine - No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years - No serious infection - No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer biologic therapy Chemotherapy - See Disease Characteristics - Recovered from prior chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - Recovered from prior radiotherapy - No concurrent anticancer radiotherapy - Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective Surgery - At least 4 weeks since prior major surgery and recovered Other - More than 28 days since prior investigational drugs, including analgesics or antiemetics - At least 4 weeks since prior myelosuppressive therapy - No other concurrent anticancer therapy - No other concurrent anticancer cytotoxic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
University of New Mexico Cancer Research and Treatment Center *Recruiting*
Albuquerque, New Mexico, 87131-5636
United States
Recruiting Claire Verschraegen 505-272-5837
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Haralambos Raftopoulos 212-305-0591
Additional Information:
Study ID Numbers: CDR0000339345; DAIICHI-1027A-PRT008,CPMC-IRB-20031085
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072228
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Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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