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OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer Clinical research trials and OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer. OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer  OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
For Condition: stage 3 rectal cancer,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer,stage 3 colon cancer,recurrent colon cancer
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining OSI-7904L with oxaliplatin in treating patients who have refractory or recurrent advanced colorectal cancer.
Details: OBJECTIVES: Primary - Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer. - Determine the maximum tolerated dose of this regimen in these patients. - Determine a safe dose for this regimen in these patients. Secondary - Determine the pharmacokinetic profile of this regimen in these patients. - Determine the safety profile of this regimen in these patients. - Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study. Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive treatment at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 3-25 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 confirmed colorectal cancer - Radiologic evidence of advanced disease - At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan - Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field - Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease - Disease progression during chemotherapy OR within 6 months after completion of treatment - No symptomatic brain metastases meeting any of the following criteria: - Unstable - Inadequately controlled with fixed-dose oral steroids - Potentially life-threatening - Required radiotherapy with the past 28 days PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin < 1.5 times ULN - No hepatitis - No cirrhosis Renal - Creatinine < 1.5 times ULN Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - HIV negative - No preexisting neuropathy grade 2 - No active or uncontrolled infection - No other serious illness or medical condition - No chronic alcohol abuse - No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin - No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - At least 21 days since prior immunotherapy - At least 21 days since prior monoclonal antibody therapy Chemotherapy - See Disease Characteristics - At least 21 days since prior chemotherapy and recovered* - No prior oxaliplatin NOTE: *Alopecia allowed Endocrine therapy - See Disease Characteristics - At least 21 days since prior hormonal therapy Radiotherapy - See Disease Characteristics - At least 21 days since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of bone marrow reserve Surgery - Recovered from prior surgery Other - At least 21 days since prior tyrosine kinase inhibitor therapy - More than 21 days since prior investigational agents - No other concurrent anticancer therapy - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickSchoffski, Study Chair, Medizinische Hochschule Hannover
Centre Leon Berard *Recruiting*
Lyon, , 69373
France
Recruiting Jean Droz 33-04-7878-2828
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Patrick Schoffski 49-511-532-9123
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Gordon Jayson 44-161-446-3000
Additional Information:
Study ID Numbers: CDR0000360667; OSI-EORTC-16033,EORTC-16033
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081237
Other Stage 3 Colon Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer
2. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
3. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
4. R115777 in Treating Patients With Advanced Colorectal Cancer
5. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Clinical Trials
Other Hannover Clinical Trials
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
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