NCT03989830 - Second-Line Chemotherapy Combined With Endostatin for Recurrent/Metastatic HN Epithelial Tumors | Crick

Overview

The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.

The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. New agent for second-line treatment of recurrent and/or metastatic head and neck tumors is urgently needed. Recombinant human endostatin is an anti-angiogenetic target drug, which has been demonstrated a good efficacy for NSCLC. Studies about recombinant human endostatin in head and neck cancer mainly focus on NPC. And phase I study of endostatin combined with chemotherapy and/or radiotherapy for NPC showed a promising results. This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

53

Conditions

Head and Neck Neoplasms

Interventions

second-line chemotherapyDRUG

choose appropriate regimen according to efficacy and adverse effects of first-line chemotherapy. q3W regimen, 6 cycles.

Recombinant human endostatinDRUG

7.5mg/m2/d，continuous intravenous pumping in 2ml/h for 5 days each cycle. Endostar(d-7) begins one week before chemotherapy(d0), first 5-day-pump(d-7 to d-2, 240ml, 2ml/h). Second 5-day-pump begins two days later (d1 to d5). the rest pumps can be done in the same manner. Three 5-day-pumps can be done during one chemotherapy cycle. Endostar will be pumped 18 weeks during 6 cycles'second-line chemotherapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years old，\<70 years old. 2. KPS ≥70. 3. Histopathology confirmed head and neck epithelial tumors, ie. Squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, et al. 4. Relapse or metastasize after fist-line platinum-based chemotherapy，and the lesions cannot be re-irradiated or re-operated. 5. At least one measurable lesion (RECIST 1.1 version). 6. Life expectancy ≥ 6 months. 7. Adequate bone function: WBC≥3.0x109/L, ANC≥1.5 x109/L, HB≥90g/L, PLT≥100 x109/L. AST, ALT, Creatinine, urea nitrogen\<1.25 ULN, normal coagulation function parameters. Exclusion Criteria: 1. Malignant melanoma, lymphoma, other tumors from mesenchymal tissues. 2. Second primary malignant tumors. 3. Contraindications of chemotherapy: severe infections, significant cardiovascular disease, symptomatic arrythmia, uncontrolled diabetes mellitus, et al. 4. HIV infection, untreated chronic hepatitis B infection or carriers of HBV DNA copies \>500IU/ml, active hepatitis C patients. 5. Uncontrolled hypertension. 6. Hemorrhagic tendency. 7. Epileptic seizure. 8. History of progression after anti-angiogenic target treatment. 9. History of allergy to recombinant human endostatin. 10. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. 11. Receiving treatment of other clinical trials.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Disease Control Rate (DCR)

include complete remission, partial remission, and stable disease

Time frame: From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months

Secondary Outcomes

Objective Response Rate (ORR)

include complete remission and partial remission

Time frame: From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months

Progress Free Survival (PFS)

1，2 years PFS

Time frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Overall Survival (OS)

1，2 years OS

Time frame: From the date of first drug administration until the date of death, assessed up to 36 months

Central Contacts

Sun Yan, MD

CONTACT

0086-10-88196217 lisaysun@139.com

Xiao Shaowen, MD

CONTACT

0086-01-88196010 docxsw11@163.com