Endostar Combined With Paclitaxel and Nedaplatin in Treating Patients With Recurrent or Metastatic Esophageal Cancer

NCT02350517 | Completed Phase 2 DMC

• 1 other identifier: Endo-17
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or metastatic esophageal squamous cell cancer.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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 24 months

Secondary Outcomes (4)

• Overall survival

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

• Overall response rate (ORR)

  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 24 months

• Number of participants with AEs and SAEs as a measure of Safety

  Each follow up vist, assessed up to 2 years

• Quality of life

  Time from day 1 to date of death, assessed up to 3 years

Study Arms (1)

Paclitaxel+Nedaplatin+Endostar

EXPERIMENTAL

Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14.

Drug: Paclitaxel+Nedaplatin+Endostar

Interventions

Paclitaxel+Nedaplatin+Endostar DRUG

Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14

Also known as: Paclitaxl, Nedaplatin, Endostar, Recombinant Human Endostatin Injection

Paclitaxel+Nedaplatin+Endostar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have provided a signed Informed Consent Form
• Age: 18-75 years old
• Histologically confirmed diagnosis of recurrent or metastatic or unresectable advanced esophageal squamous cell carcinoma
• Patients have neither received any palliative chemotherapy nor adjuvant chemotherapy or concurrent chemotherapy with taxane based drugs or large doses cisplatin (cumulative dose ≥ 300mg/m2). The time from the last adjuvant or concurrent chemotherapy to relapse or metastasis should more than 6 months.
• Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria; Targeted lesions should not include primary esophageal lesions
• Life expectancy ≥ 3 months
• Karnofsky score ≥70
• Patient has adequate bone marrow and organ function
• Leukocyte ≥ 3.5 x 10\^9/L
• eAbsolute Neutrophil Count (ANC) ≥ 1.8 x 10\^9/L
• Platelets ≥ 90 x 10\^9/L
• Hemoglobin ≥ 10g/L
• Patient has adequate liver function
• AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
• Serum bilirubin ≤ 1.2 x ULN

You may not qualify if:

• Patients have received radiotherapy in 3 months.
• Patients with relapse recurrent or metastatic lesions in radiated area.
• Patient has received previous treatment with VEGF inhibitors
• Known severe hypersensitivity to the drugs in the experimental chemotherapy or any of the excipients of these products
• Patients without measureable lesions
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases
• Patients with chronic diarrhea
• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
• psychiatric illness including CNS metastases that would prevent the patient from giving informed consent
• Pregnant or lactating women

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nedaplatin; endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Yu-hong Li, MD, Ph D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ph D

Study Record Dates

• First Submitted: January 24, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)