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Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer



Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer. - Determine the qualitative and quantitative toxicities of this regimen in these patients. - Determine the therapeutic response to this regimen in these patients. - Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients. - Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients. OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3000/mm^3 - Absolute neutrophil count at least 1500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No neuropathy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No allergy to platinum compounds or antiemetics - No uncontrolled concurrent illness - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 2 prior chemotherapy regimens - No prior oxaliplatin or paclitaxel - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow Surgery: - Not specified Other: - No other concurrent investigational agents - No concurrent antiretroviral therapy for HIV (HAART)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EricKraut,  Study Chair,  Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 


Additional Information:
Study ID Numbers:  CDR0000067419;  OSU-99H0284,NCI-T99-0017
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004173

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors

2. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

3. Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors

4. CP-609,754 in Treating Patients With Advanced Solid Tumors

5. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer

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