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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel+Nedaplatin+Endostar

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
- Creatinine ≤ 1.2 times ULN
- Alkaline phosphatase ≤ 5.0 times ULN
No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.
Patients with effective contraceptive measures
Expect good compliance

Exclusion Criteria:

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

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel+Nedaplatin+Endostar

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Overall response rate (ORR)

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

Each follow up visit, assessed up to 3 years. Date will be assessed at each study visiting using NCI CTCAE version 4.0.

Quality of life

Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18

Full Information

NCT ID

NCT02350517

First Posted

January 24, 2015

Last Updated

February 14, 2023

Sponsor

Yuhong Li

1. Study Identification

Unique Protocol Identification Number

NCT02350517

Brief Title

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

Official Title

A Phase II Trial of Recombinant Human Endostatin Injection (Endostar) Combined With Paclitaxel and Nedaplatin as First-line Therapy in Treating Patients With Recurrent or Metastatic Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yuhong Li

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The prognosis of recurrent or metastatic esophageal squamous cell cancer is poor. However, there is still no standard chemotherapy regimen recommended for this disease because of the lack of trails. Currently, anti-angiogenesis therapy had been proved to improve the survival successfully in colorectal cancer, non-small cell lung cancer, breast cancer, glioma and kidney cancer. Recent studies showed that the high level of VEGF was negative correlated with the prognosis of esophageal cancer. Endostar, as a novel endogenous angiogenesis inhibitors, was proved to significantly inhibited the proliferation and metastasis in esophageal cell lines and animal models. A retrospective study also reported the safety and efficacy of the combination therapy of paclitaxel liposome and recombinant human endostatin. Based on the basis above, we designed this phase Ⅱ study 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel+Nedaplatin+Endostar

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel+Nedaplatin+Endostar

Other Intervention Name(s)

Paclitaxl, Nedaplatin, Endostar, Recombinant Human Endostatin Injection

Intervention Description

Primary Outcome Measure Information:

Title

Progression free survival

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 24 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

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

Title

Overall response rate (ORR)

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 24 months

Title

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

Description

Each follow up visit, assessed up to 3 years. Date will be assessed at each study visiting using NCI CTCAE version 4.0.

Time Frame

Each follow up vist, assessed up to 2 years

Title

Quality of life

Description

Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Creatinine ≤ 1.2 times ULN Alkaline phosphatase ≤ 5.0 times ULN No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃. Patients with effective contraceptive measures Expect good compliance Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-hong Li, MD, Ph D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

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

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