Clinical trial · Interventional
Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)
NCT00620295CI-TRIAL-00030594completedPhase 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 solid tumors by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, 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 gemcitabine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and gemcitabine in treating older patients with advanced solid tumors.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine / Bortezomib
- description
- Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose on day 1 and day 8 of a 21 day cycle. Bortezomib will be given 1 hour after gemcitabine by IVP over 3 to 5 seconds followed by a standard saline on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
- interventionNames
- Drug: bortezomib
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Maximum tolerated dose of bortezomib and gemcitabine
- timeFrame
- Day 21 (Week 3 - Cycle 1)
- description
- A minimum of a 3 week period (1 cycle) must be completed by all patients within a dose level before dose escalation to the next level may occur. A cycle is defined as treatment day 1 and 8 with follow-up through day 21.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced non-hematologic malignancy, including any of the following: * Breast cancer * Lung cancer * Colon cancer * Pancreatic cancer * Head and neck cancer * Sarcoma * Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy (for all diseases except pancreatic cancer) * Pancreatic cancer patients may be enrolled with no prior therapy requirements since gemcitabine is the current standard of care 1st line therapy * Measurable or nonmeasurable disease * Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required * ECOG performance status of 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement) * Calculated or measured creatinine clearance \> 30 mL/minute * Fertile patients must use effective contraception during and for 3 months after study participation * Recovered from all prior therapy * Prior systemic chemotherapy, immunotherapy, or biological therapy allowed * At least 3 months since prior bortezomib and/or gemcitabine * At least 2 weeks since prior systemic therapy * At least 3 weeks since prior investigational agents (for reasons other than the treatment of cancer) * At least 2 weeks since prior radiotherapy Exclusion Criteria: * Symptomatic brain metastases * Serious concomitant medical or psychiatric disorders (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study * Myocardial infarction within the past 6 months * New York Heart Association (NYHA) Class III or IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Peripheral neuropathy ≥ grade 2 * Known hypersensitivity to bortezomib, boron or mannitol * Prior radiotherapy to ≥ 25% of the bone marrow * Prior radiotherapy to the whole pelvis * Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.