Clinical trial · Interventional
Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy
NCT00027898CI-TRIAL-00009352completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib, carboplatin, and etoposide)
- description
- 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.
- interventionNames
- Drug: bortezomib
- Drug: carboplatin
- Drug: etoposide
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- MTD defined as the dose level below the dose level that results in DLT in >= 2 of 6 new patients assessed using NCI CTC version 2.0
- timeFrame
- 21 days
- measure
- Biological data
- timeFrame
- Up to 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced solid tumor cancer for which no curativetherapy 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 * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 9 g/dL * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 2.5 times upper limit of normal * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * 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) * No prior bone marrow or peripheral blood stem cell transplantation * No concurrent immunotherapy * 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 * See Disease Characteristics * No concurrent hormonal therapy * 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 * At least 28 days since prior investigational agents * No other concurrent experimental medications
References
Publications (0)
Data not yet available
No reference posted for this study.