Clinical trial · Interventional
Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
NCT00052689CI-TRIAL-00012332completedPhase 2ClinicalTrials.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)
Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with gemcitabine may kill more tumor cells.
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 |
|---|---|---|---|
| Duct Cell Adenocarcinoma of the Pancreas | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.
- interventionNames
- Drug: bortezomib
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
- interventionNames
- Drug: bortezomib
- Drug: gemcitabine hydrochloride
Primary outcomes (2)
- measure
- Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic ductal or undifferentiated adenocarcinoma consistent with a pancreatic primary for which no standard curative measures exist * No locally advanced disease only * No islet cell, acinar cell, or cystadenocarcinomas * Measurable disease * At least one lesion whose longest diameter can be accurately measured as 2 cm or greater by conventional techniques OR 1 cm or greater by spiral CT scan * A tumor lesion in a previously irradiated area allowed provided it is histologically confirmed disease with radiographic progression from a post-radiotherapy CT scan * No CNS metastasis * Performance status - ECOG 0-2 * At least 3 months * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (stents allowed) * AST no greater than 5 times ULN * PT and PTT no greater than ULN\* * Creatinine no greater than 1.5 times ULN * No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No neuropathy greater than grade 1 * No underlying disease state associated with active bleeding * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * More than 4 weeks since prior biologic therapy or immunotherapy * No concurrent immunotherapy * No concurrent colony-stimulating factors during the first course of the study * No prior gemcitabine (even as a radiosensitizing agent) * No prior chemotherapy * Radiosensitizing agent as adjuvant therapy or for locally advanced disease allowed * No other concurrent chemotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No prior radiotherapy to 25% or more of the bone marrow * No concurrent radiotherapy * No prior bortezomib
References
Publications (0)
Data not yet available
No reference posted for this study.