Clinical trial · Interventional
Bortezomib Followed by the Addition of Doxorubicin at Disease Progression in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (Cancer) of the Head and Neck
Phase II Trial of PS-341 (NSC 681239) Followed by the Addition of Doxorubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck
NCT00077428CI-TRIAL-00009120completedPhase 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)
This phase II trial is studying how well bortezomib followed by doxorubicin at the time of disease progression works in treating patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (cancer) of the head and neck. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | CURATED_BROADER | 0.78 |
| Salivary Gland Adenoid Cystic Carcinoma | Salivary Gland Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib, doxorubicin hydrochloride)
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression continue to receive bortezomib as above and doxorubicin IV over 2-5 minutes on days 1 and 8. Treatment repeats every 21 days for up to 14 courses in the absence of further disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
- Drug: doxorubicin hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective tumor response (complete and partial overall response) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Up to 10 years
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenoid cystic carcinoma of the head and neck * Locally advanced, recurrent, or metastatic disease that is considered incurable by known therapies * Unidimensionally measurable disease * Must not have stable disease for at least 9 months before study entry * No known brain metastases * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * AST and ALT no greater than 2.5 times upper limit of normal * Bilirubin normal * Creatinine normal * Creatinine clearance at least 60 mL/min * LVEF at least lower limit of normal by MUGA * No history of congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active or ongoing infection * No prior allergy to compounds of similar chemical or biological composition to bortezomib * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No pre-existing neuropathy \> grade 1 * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * See Chemotherapy * No prior anthracyclines, including any of the following: * Doxorubicin * Epirubicin * Daunorubicin * Idarubicin * No prior mitoxantrone * No prior high-dose chemotherapy for bone marrow transplantation * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * At least 3 weeks since prior radiotherapy * At least 3 weeks since prior surgery * More than 4 weeks since prior investigational drugs * No other concurrent anticancer therapy or agents
References
Publications (0)
Data not yet available
No reference posted for this study.