Cyclophosphamide for Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT02794077|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Nasopharyngeal Undifferentiated Carcinoma Stage IV Nasopharyngeal Undifferentiated Carcinoma||Drug: Cyclophosphamide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metronomic Oral Cyclosphosphamide as Third-line Systemic Treatment or Beyond in Patients With Inoperable Locoregionally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||June 2016|
Patients receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progression or unacceptable toxicity.
Patient receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progressive or unacceptable toxicity.
Other Name: Endoxan
- Progression-free survival [ Time Frame: 12 months ]Interval between the date of commencement of cyclophosphamide to the date of radiologically confirmed progressive disease or death, whichever comes earlier.
- Objective response rate [ Time Frame: 12 months ]The percentage of patients who demonstrate complete response or partial response after study medication as assessed by RECIST 1.1
- Disease control rate [ Time Frame: 12 months ]The percentage of patients who demonstrate complete response, partial response or stable disease after study medication as assessed by RECIST 1.1
- Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 12 months ]All treatment-related adverse events as assessed by CTCAE version 4.0 will be recorded
- Overall survival [ Time Frame: 36 months ]Time interval between the date of commencement of cyclophosphamide to the date of death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794077
|Principal Investigator:||Victor Lee, MD||Department of Clinical Oncology, The University of Hong Kong, Hong Kong|