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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Squamous Cell Carcinoma Of The Head And Neck

Treatments: Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03830385

B2018-138

Details and patient eligibility

About

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

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or

Experimental group

Treatment:

Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin