Efficacy and Safety of TC+AVASTIN Versus TC in Patients With Metastatic Nasopharyngeal Carcinoma

NCT02250599 | Unknown Phase 2 DMC

• 1 other identifier: ML29153
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief Summary

The present study will be a randomized, control, multicenter phase II study of metastatic nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H\&N35 are used to measure PRO outcome for this study.

Conditions

Nasopharyngeal Neoplasms

Keywords

Metastatic Nasopharyngeal Carcinoma; treatment

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  3 years

Secondary Outcomes (6)

• Overall survival(OS)

  3 years

• Overall response rate (ORR,CR+PR)

  3 years

• Disease control rate(DCR,CR+PR+SD)

  3 years

• Health-related quality of life

  3 years

• Number of Participants with Adverse Events

  3 years

Study Arms (2)

carboplatin and paclitaxel

ACTIVE COMPARATOR

carboplatin and paclitaxel :paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle

Drug: Paclitaxel; Drug: Carboplatin

AVASTIN and carboplatin and paclitaxel

EXPERIMENTAL

AVASTIN and carboplatin and paclitaxel: Bevacizumab(AVASTIN) 7.5 mg/kg intravenously (IV) infusion on Day 1 of each 3-week cycle; paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle

Drug: Paclitaxel; Drug: Bevacizumab; Drug: Carboplatin

Interventions

Paclitaxel DRUG

Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle

AVASTIN and carboplatin and paclitaxel; carboplatin and paclitaxel

Bevacizumab DRUG

Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle

Also known as: AVASTIN

AVASTIN and carboplatin and paclitaxel

Carboplatin DRUG

Carboplatin AUC 6 IV Day 1 each 3-week cycle

AVASTIN and carboplatin and paclitaxel; carboplatin and paclitaxel

Eligibility Criteria

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

You may qualify if:

• Patients must meet the following criteria for study entry:
• Age ≥ 18
• Eastern Cooperative Oncology Group (ECOG) performance status 0\~1
• Patients with a life expectancy\>12 weeks
• Histologically proven NPC diagnosis
• Metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment(in terms of some relevant therapy for anti-tumor like surgery, radiofrequency ablation, transcatheter arterial chemoembolization(TACE) and radiotherapy(except palliative radiotherapy for metastatic bone pain with appropriate radiation dosage without influence to the hemogram),etc.)
• Neoadjuvant or concurrent chemoradiotherapy was allowed, provided that the treatment was completed at least 3 months before the start of study drug treatment
• ≥1 measurable target based on RECIST criteria
• Adequate bone marrow, hepatic and renal function, defined as follows within 1 weeks prior to randomization
• Patients must sign study specific informed consent prior to registration
• Patient must have recovered (be \>28 days post-surgery) from the effects of surgery, postoperative infection, and other complications before initial treatment with bevacizumab
• Systolic blood pressure ≤ 160 mmHg and diastolic pressure ≤ 90 mmHg within 7 days prior to randomization.

You may not qualify if:

• Prior systemic treatment for metastatic nasopharyngeal carcinoma
• Preparing for receiving local treatment for metastatic nasopharyngeal carcinoma (excluding palliative irradiation to release skeletal pain)
• Prior treatment with bevacizumab or other agents specifically targeting VEGF
• Patients with hemorrhage tendency including acute hemorrhage of digestive tract, nasal bleeding （not including nasal epistaxis), continuous hemorrhagic disease or Coagulation function disorder disease. Patients are using known NSAIDS to inhibit platelets.
• Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon or more or frank clots within minimal or no phlegm per coughing episode) within 4 weeks prior to registration; patients with incidental blood mixed with phlegm are not excluded
• Patients receiving other experimental therapeutic cancer treatment
• Severe, active co-morbidity, defined as follows:
• i.--Unstable angina and/or congestive heart failure or vascular (e.g. aortic aneurysm requiring surgical repair or peripheral thrombosis) disease requiring hospitalization within the last 12 months, or other cardiac compromise (e.g. an inadequately controlled cardiac arrhythmia) that in the judgment of the investigator will preclude the safe administration of a study drug; Patient must not show sign of recent myocardial infarction or ischemia by the findings of S-T elevations of ≥ 2mm on an EKG ii.--History of arterial thromboembolic events, venous thromboembolism \>NCI CTCAE Grade 3, transient ischemic attack (TIA), cerebral vascular accident (CVA), transmural myocardial infarction (MI), or hypertensive crisis or hypertensive encephalopathy iii.--History of ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy iv.--Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration v.--History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active GI bleeding within the last 6 months prior to registration; vi.--Esophageal varices, non-healing ulcer, non-healing wound, or bone fracture within the last 6 months prior to registration vii.--Active, untreated infection and/or acute bacterial or fungal infection uiring intravenous antibiotics at the time of registration viii.--Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; ix. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects x. - Minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment
• Patients currently (within 10 days of study enrollment) taking warfarin, heparin, daily treatment with aspirin (\> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function; treatment with dipyramidole, ticlopidine, clopidogrel, or cilostazol
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception;
• Prior allergic reaction to the study drug(s) involved in this protocol
• Contraindication to Bevacizumab
• Patients has another cancer history （not NPC）within 5 years before randomization.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (8)

Dongguan People's Hospital

Dongguan, Guangdong, China

RECRUITING

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

Related Publications (1)

• Zhou T, Yang Y, Ma S, Lin L, Zhou T, Zhang C, Ding X, Wang R, Feng G, Chen Y, Xu R, Huang Y, Zhang L. Bevacizumab versus placebo in combination with paclitaxel and carboplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase II trial. ESMO Open. 2021 Dec;6(6):100313. doi: 10.1016/j.esmoop.2021.100313. Epub 2021 Nov 24.

  PMID: 34837744 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma

Interventions

Paclitaxel; Bevacizumab; Carboplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Study Officials

• li zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profressor

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 26, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

CN (8)