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
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.
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.
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.
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Exclusion Criteria:
Patients receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progression or unacceptable toxicity.
Drug: Cyclophosphamide
Patient receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progressive or unacceptable toxicity.
Also known as: Endoxan
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
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
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
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
Overall survival
Time interval between the date of commencement of cyclophosphamide to the date of death
Time frame: 36 months
No study locations are listed for this record.
Plan to share: No — There is no plan for to make individual participant data available.
No publications or documents are linked to this record.
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.
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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