Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03830385
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma Of The Head And Neck	Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
• Actual Study Start Date: Feb 15, 2019
• Anticipated Primary Completion Date: Feb 15, 2021
• Anticipated Study Completion Date: Feb 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or	Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin; All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy

Outcome Measures

Primary Outcome Measures

1. overall survival [5 years]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• biopsy proved squamous cell carcinoma of the head and neck;

• stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;

• 18 years or older; without other malignancy;

• proper functioning of the major organs.

Exclusion Criteria:

• allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;

• female within gestation period or lactation;

• patients received drug of other clinical trial within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingqing Cai, Chief physician, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03830385
• Other Study ID Numbers: B2018-138
• First Posted: Feb 5, 2019
• Last Update Posted: Jul 16, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carboplatin; Bleomycin

Study Results

No Results Posted as of Jul 16, 2019