Clinical trial · Interventional
Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer
Phase II Trial of PS-341 (Bortezomib, NSC-681239) Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT00305734CI-TRIAL-00009149completedPhase 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 giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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
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 |
|---|---|---|---|
| Recurrent Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib, gemcitabine hydrochloride)
- description
- Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses of treatment with bortezomib. Patients who experience disease progression on single-agent bortezomib and did not receive prior gemcitabine hydrochloride may begin combination therapy within 10-28 days of the last dose of bortezomib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and bortezomib IV on days 1, 4, 8, 11. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond the confirmed CR.
- interventionNames
- Drug: bortezomib
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Objective response rate (confirmed and unconfirmed, complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST) in patients treated with bortezomib
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed nasopharyngeal carcinoma (NPC) of one of the following subtypes: * Non-keratinizing (WHO type II) * Undifferentiated (WHO type III) * Disease meets one of the following stage criteria: * Stage IVC at diagnosis * Persisted, metastasized, or recurred after definitive surgery, radiotherapy, and/or chemotherapy * Measurable disease * If only measurable disease is within a prior radiation therapy port, disease progression must be clearly demonstrated * No known CNS metastases * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin normal * SGOT or SGPT ≤ 2.5 times ULN * Zubrod performance status 0-2 * No peripheral neuropathy \> grade 1 * No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years * Not pregnant or nursing * Fertile patients must use effective contraception * More than 6 months since prior myocardial infarction * No New York Heart Association class III or IV cardiac problems * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No acute ischemia by ECG * No active conduction system abnormalities * No known hypersensitivity to bortezomib, boron, or mannitol * See Disease Characteristics * No prior therapy with gemcitabine hydrochloride, bortezomib, or other proteasome inhibitors * No more than 28 days since discontinuation of single-agent bortezomib * Patients with prior gemcitabine hydrochloride treatment are eligible for single-agent bortezomib treatment but NOT for combination treatment * No more than one prior chemotherapy regimen for the treatment of metastatic or recurrent NPC * At least 28 days since prior treatment and recovered * At least 24 weeks since prior adjuvant chemotherapy * At least 24 weeks since prior chemotherapy as a radiosensitizer for initial locally advanced disease * At least 28 days since prior radiotherapy and recovered * At least 28 days since prior surgery and recovered * No other concurrent therapy for NPC, including any of the following: * Radiotherapy * Chemotherapy * Immunotherapy * Biologic therapy * Other investigational drugs * Gene therapy * No colony-stimulating factor therapy during the first course of study therapy * No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.