Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study

NCT04850235 | Unknown Phase 1

• 1 other identifier: 2020-FXY-489
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Capecitabine is the precursor drug of 5-fluorouracil, and has been used in replace of 5-fluorouracil in NPC patients. Nab-paclitaxel (Nab-PTX) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel. We sought to find out the efficacy of Nab-PTX in three-drug triplet (Nab-PTX, DDP and capecitabine) and decide the best administration dose of Nab-PTX.

Conditions

Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  If more than one-third of patients in a given cohort experienced a dose-limiting toxicity (DLT), enrollment will be stopped and the dose used in the previous cohort will be designated as the maximum tolerated dose

  At the end of each cycle (each cycle is 21 days)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence rate of adverse events (AEs), evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria.

  At the end of each cycle (each cycle is 21 days)

Secondary Outcomes (4)

• Objective response rate

  3 months

• Disease control rate

  3 months

• Overall survival

  2-year

• Progression-free survival

  2-year

Study Arms (1)

TPX neoadjuvant chemotherapy +CCRT

EXPERIMENTAL

Patients receive neoadjuvant chemotherapy with Nab-PTX (150/175/200/225/250 mg/m2, D1) , cisplatin (75 mg/m2, D1) and capecitabine (1000 mg/m2, BID, D1-14) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100 mg/m2) concurrent every three weeks during radiotherapy (D1, D22, D43 of RT)

Drug: Nab paclitaxel

Interventions

Nab paclitaxel DRUG

Nab paclitaxel plus cisplatin and capecitabine as neoadjuvant chemotherapy

TPX neoadjuvant chemotherapy +CCRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
• Original clinical staged as III-IVa （according to the 8th AJCC edition).
• No evidence of distant metastasis (M0).
• Male and no pregnant female.
• Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
• WBC ≥ 4×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L.
• With normal liver function test (ALT/AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN).
• With normal renal function test (Creatinine Clearance ≥ 60 ml/min ).

You may not qualify if:

• Patients have evidence of relapse or distant metastasis.
• Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
• Receiving radiotherapy or chemotherapy previously.
• The presence of uncontrolled life-threatening illness.
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Receiving other ways of anti-cancer therapy.
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Yu-Chen, Luo MJ, Liu RP, Jin J, Deng SW, Tang LQ, Li XY, Liu LT, Luo DH, Sun R, Liu SL, Li JB, Liu Q, Wang P, Chen QY, Mai HQ, Guo SS. Phase I dose-escalation study of nab-paclitaxel combined with cisplatin and capecitabin as induction chemotherapy followed by concurrent chemoradiotherapy in patients with nasopharyngeal carcinoma. Radiother Oncol. 2024 Feb;191:110051. doi: 10.1016/j.radonc.2023.110051. Epub 2023 Dec 21.

  PMID: 38135184 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Taxes

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 20, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)