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CompletedNCT02794077Updated Oct 2, 2019

Cyclophosphamide for Nasopharyngeal Carcinoma

A Phase 2 interventional study of Cyclophosphamide in Recurrent Nasopharyngeal Undifferentiated Carcinoma and Stage IV Nasopharyngeal Undifferentiated Carcinoma, sponsored by The University of Hong Kong. Completed. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by The University of Hong Kong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
15 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

NPC is endemic in Southern China including Hong Kong. Despite aggressive definitive chemoradiotherapy for locoregionally advanced disease, still about 30% develop relapse locoregionally or distally. Salvage or second-course radical radiotherapy with or without chemotherapy may achieve durable disease control for locoregionally advanced recurrent disease. However for those who had received 2 courses of radical radiotherapy or those with distant metastases, systemic chemotherapy would be the only drug of choice. Platinum-based doublet chemotherapy including cisplatin + 5-fluorouracil, capecitabine, gemcitabine or taxane is considered the standard first-line treatment. For second-line treatment, whether platinum-based chemotherapy was given previously is a consideration. Re-challenge with cisplatin and 5-fluorouracil can be considered in patients who enjoyed a good initial response to the same regimen with an intervening disease-free period of more than 1 year.However so far there has been no recognized standard third-line systemic treatment. Metronomic oral chemotherapy may provide an ideal choice patients treated in this setting by shifting the targets from tumor cells to tumor vasculature so as to reduce the chance of drug resistance as well as offering a relatively low toxicity profile to them who have been significantly jeopardized by the long-term complications brought prior courses of radiation therapy, surgery and chemotherapy.

In view of the above, we investigated metronomic open-label oral cyclophosphamide as third-line treatment or beyond in patients with inoperable locoregionally advanced recurrent or metastatic NPC who had failed at least 2 lines of prior systemic chemotherapy.

02

Conditions studied

  • Recurrent Nasopharyngeal Undifferentiated Carcinoma
  • Stage IV Nasopharyngeal Undifferentiated Carcinoma

Keywords

  • Nasopharyngeal undifferentiated carcinoma
03

In context

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Cyclophosphamide

    Patients receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progression or unacceptable toxicity.

    Drug: Cyclophosphamide

Interventions

  • Patient receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progressive or unacceptable toxicity.

    Also known as: Endoxan

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Interval between the date of commencement of cyclophosphamide to the date of radiologically confirmed progressive disease or death, whichever comes earlier.

    Time frame: 12 months

Secondary outcomes

  1. Objective response rate

    The percentage of patients who demonstrate complete response or partial response after study medication as assessed by RECIST 1.1

    Time frame: 12 months

  2. Disease control rate

    The percentage of patients who demonstrate complete response, partial response or stable disease after study medication as assessed by RECIST 1.1

    Time frame: 12 months

  3. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0

    All treatment-related adverse events as assessed by CTCAE version 4.0 will be recorded

    Time frame: 12 months

  4. Overall survival

    Time interval between the date of commencement of cyclophosphamide to the date of death

    Time frame: 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — There is no plan for to make individual participant data available.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Dec 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2016
First posted
Jun 8, 2016
Start
Jan 2008
Primary completionActual
Dec 2015
CompletionActual
Jun 2016
Last update
Oct 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02794077
Responsible party
Dr. Victor H.F. Lee (Clinical Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Jun 8, 2016
Start date
Jan 2008
Primary completion
Dec 2015
Completion
Jun 2016
Last update
Oct 2, 2019

Study contacts

Victor Lee, MD
principal investigator · Department of Clinical Oncology, The University of Hong Kong, Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cyclophosphamide

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