second-line chemotherapy combined with endostatin for recurrent/metastatic hn epithelial tumors

Conditions: Head and Neck Neoplasms

Summary: 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.

Eligibility criteria:
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.

Keywords: endostatins head and neck neoplasms