Clinical trial · Interventional
Bortezomib and Topotecan in Treating Patients With Advanced Solid Tumors
Phase I Study of Weekly Bortezomib (VELCADE, PS-341) and Weekly Topotecan (HYCAMTIN) in Solid Tumor Patients With an Emphasis on Small Cell Lung Cancer (SCLC)
NCT00388089CI-TRIAL-00003608completedPhase 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)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with topotecan may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and topotecan in treating patients with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
- timeFrame
- Monitored on an ongoing basis during the study
- description
- If cumulative toxicities are seen in subsequent treatment cycles, a decision regarding modification or discontinuation of the study drug and/or patient enrollment will be made by the sponsor in conjunction with the investigator.
Secondary outcomes (11)
- measure
- Toxicity
- timeFrame
- On Day 8 and at beginning of subsequent cycles
- description
- Toxicity will be evaluated based on the standard NCI CTC grading criteria version 3.0.
- measure
- Response rate
- timeFrame
- At baseline and every 2 courses during treatment
- description
- As assessed by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor, meeting 1 of the following criteria: * Disease progressed after ≥ 1 prior standard therapy regimen * Treatment-naive with no standard therapy of curative intent available * Not a candidate for standard therapy due to poor performance status * Patients with small cell lung cancer are enrolled after the maximum tolerated dose has been determined * Must have tumor accessible for biopsy * Measurable disease by RECIST criteria or evaluable disease (e.g., pleural effusion, ascites, or bone metastasis) * Disease in previously irradiated sites is considered measurable provided there is clear disease progression after radiotherapy * Asymptomatic brain metastasis treated by prior surgical resection or radiotherapy allowed if both of the following criteria are met: * Neurologically stable * Off steroids and anticonvulsants for ≥ 4 weeks PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine clearance ≥ 40 mL/min * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3.0 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No preexisting neuropathy ≥ grade 2 within the past 14 days * No hypersensitivity to bortezomib, boron, or mannitol * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Any number of prior chemotherapy regimens allowed * At least 4 weeks since prior chemotherapy and recovered * At least 2 weeks since prior radiotherapy and recovered * No prior topotecan hydrochloride or bevacizumab * At least 14 days since prior investigational drugs * No concurrent anticonvulsants metabolized by the cytochrome P450 pathway
References
Publications (0)
Data not yet available
No reference posted for this study.