Clinical trial · Interventional
Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Phase II and Pharmacodynamic Study of PS-341 in Patients With Unresectable or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was discontinued early due to no confirmed partial responses.
Summary
Brief summary (as posted)
This phase II trial is studying how well bortezomib works as first-line systemic therapy in treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Extrahepatic Bile Duct | Extrahepatic Bile Duct Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Gallbladder | Gallbladder Adenocarcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Up to 1 year
- description
- Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.
Secondary outcomes (5)
- measure
- Time to Disease Progression
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Absolute neutrophil count \>= 1,500/mm3 * No psychiatric illness or social situation that would preclude study compliance * Chemotherapy administered solely as a radiosensitizer or as adjuvant therapy and investigational or targeted therapies (i.e., inhibitors of the epidermal growth factor receptor) will not count toward the maximum of 2 prior regimens allowed * Histologically or cytologically confirmed adenocarcinoma of the intrahepatic or extrahepatic bile duct or gallbladder: * Locally advanced or metastatic disease * At least 1 unidimensionally measurable lesion \>=20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * Not amenable to curative surgical resection * No known brain metastases * Performance status: * ECOG 0-2 * Life expectancy: * More than 12 weeks * Platelet count \>= 100,000/mm3 * WBC \>= 3,000/mm3 * AST and ALT ≤ 2.5 times upper limit of normal (ULN) \[Note: Biliary shunting or stenting allowed to achieve the required bilirubin and transaminase levels\] * Bilirubin ≤ 1.5 times ULN \[Note: Biliary shunting or stenting allowed to achieve the required bilirubin and transaminase levels\] * Creatinine within ULN OR Creatinine clearance \>= 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No symptomatic cardiac arrhythmia within the past 4 weeks * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No underlying neuropathy \>= grade 2 * No history of allergic reaction to boron, mannitol, or bortezomib * No active or ongoing infection * No concurrent uncontrolled illness * No medical or psychiatric condition that would preclude study participation * No prophylactic granulocyte or platelet growth factors (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * Prior chemotherapy as a radiosensitizer (e.g., fluorouracil or gemcitabine) with radiotherapy is allowed as adjuvant therapy after resection for locally advanced disease provided there is evidence of disease progression * No more than 2 prior chemotherapy regimens for locally advanced or metastatic disease * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No other concurrent investigational agents
References
Publications (1)
- RESULTDenlinger CS, Meropol NJ, Li T, Lewis NL, Engstrom PF, Weiner LM, Cheng JD, Alpaugh RK, Cooper H, Wright JJ, Cohen SJ. A phase II trial of the proteasome inhibitor bortezomib in patients with advanced biliary tract cancers. Clin Colorectal Cancer. 2014 Jun;13(2):81-6. doi: 10.1016/j.clcc.2013.12.005. Epub 2014 Jan 4. PMID 24512954