Clinical trial · Interventional
Cyclophosphamide for Nasopharyngeal Carcinoma
Metronomic Oral Cyclosphosphamide as Third-line Systemic Treatment or Beyond in Patients With Inoperable Locoregionally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT02794077CI-TRIAL-00040948completedPhase 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)
There is no standard third-line systemic treatment for inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). We investigated the efficacy and safety of metronomic oral cyclophosphamide as third-line treatment or beyond.
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 Undifferentiated Carcinoma | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide
- description
- Patients receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 12 months
- description
- Interval between the date of commencement of cyclophosphamide to the date of radiologically confirmed progressive disease or death, whichever comes earlier.
Secondary outcomes (4)
- measure
- Objective response rate
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable locoregionally advanced recurrent NPC of undifferentiated type beyond curative surgical resection or second and subsequent courses of radical radiotherapy or metastatic disease who all had received at least 2 lines palliative systemic chemotherapy * Adequate hematological function defined as absolute neutrophil count ≥1.5 × 10\^9/l; hemoglobin ≥9.0 g/dl and platelet ≥100 × 10\^9/l * Adequate renal function defined as serum creatinine ≤1.5 × upper normal limit * Adequate hepatic function defined as serum bilirubin ≤1.5 × upper normal limit; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper normal limit for patients without liver metastases or ≤5 × upper normal limit for those with liver metastases * Measurable disease according to the RECIST criteria (version 1.1), for the evaluation of measurable disease Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 3 or above * Known brain metastases or leptomeningeal metastases; Note: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. \> 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =\< 8 weeks of study entry, are not excluded; Note: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide * History of severe hypersensitivity reaction to any monoclonal antibody * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception Note: breastfeeding should be discontinued if the mother is treated with cyclophosphamide; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; they must adhere to contraception for a period of 31 weeks after the last dose of cyclophosphamide * For patients with unknown human immunodeficiency virus (HIV) status at the time of enrollment, HIV serology must be tested during screening; patients who are tested positive for HIV could be included if there is an adequate cluster of differentiation 4 (CD4) count (\> 350/ul) on a stable regimen of highly active anti-retroviral therapy (HAART) with no detectable or minimal viral burden, and no active infections * Those who cannot provide written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.