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Home > "B" Clinical Trials Conditions > Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors  Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Colorado Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin and etoposide in treating patients who have advanced solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of bortezomib, carboplatin, and etoposide in patients with advanced solid tumors refractory to standard therapy. - Determine the safety of this regimen at the MTD in patients with newly diagnosed, chemotherapy-naive extensive stage small cell lung cancer. OUTLINE: This is a dose-escalation study of bortezomib. Patients receive bortezomib IV on days 1 and 8, carboplatin IV over 30 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients with newly diagnosed, chemotherapy-naive extensive stage small cell lung cancer are treated at that dose. PROJECTED ACCRUAL: A total of 12-27 patients will be accrued for this study within 6-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced solid tumor cancer for which no curative therapy exists - Clinically stable CNS disease is allowed provided the following criteria are met: - No uncontrolled brain metastases or CNS involvement - No active seizures - On stable dose of antiseizure or steroid medication for at least 7 days before study enrollment PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection - No other serious concurrent systemic disorders (including other malignancy) PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow or peripheral blood stem cell transplantation - No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior carboplatin and/or etoposide allowed - No more than 2 prior courses of mitomycin Endocrine therapy: - See Disease Characteristics - No concurrent hormonal therapy Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - Palliative radiotherapy involving less than 35% bone marrow reserve allowed if completed at least 2 weeks before study enrollment - No prior wide-field radiotherapy to 35% or more of bone marrow - No prior pelvic radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - At least 28 days since prior investigational agents - No other concurrent experimental medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LiaGore, Principal Investigator, University of Colorado Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Michele Basche 720-848-0300
Additional Information:
Study ID Numbers: CDR0000069091; NCI-3171,UCHSC-COMIRB-01288
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027898
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
2. Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
3. Chemotherapy in Treating Patients With Solid Tumors
4. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
5. Irinotecan in Treating Patients With Advanced Solid Tumors
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Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
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