Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma

NCT02861690 | Completed Phase 2 DMC

• 1 other identifier: Esophageal cancer 001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma

Conditions

Esophageal Carcinoma

Keywords

Esophageal Cancer; nedaplatin; Liposomal Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Response rate

  To assess the response rate of Liposomal Paclitaxel and Nedaplatin in patients with pretreated advanced or recurrent esophageal carcinoma. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

  from date of baseline measured to date of first CT evaluation，Up to 3 months

Secondary Outcomes (3)

• progression-free survival

  from date of baseline to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• overall survival

  baseline to date of death from any cause，up to 2 approximately years

• Number of Participants With Adverse Events (Toxicity)

  Up to 30 days post last dose

Study Arms (1)

Treatment group

EXPERIMENTAL

patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity

Drug: Liposomal Paclitaxel; Drug: Nedaplatin

Interventions

Liposomal Paclitaxel DRUG

Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Treatment group

Nedaplatin DRUG

Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histological confirmed advanced metastatic or recurrent esophageal cancer
• age between 18 and 80 years
• ECOG performance status of 0 to 2
• life expectancy ≥ 12 weeks
• has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
• at least one prior chemotherapy regimen
• adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
• platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
• adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
• adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

You may not qualify if:

• other primary malignancy
• symptomatic central nervous system metastasis
• pregnancy or lactation
• cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
• ongoing infection

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

nedaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Rui-hua Xu

  Sun Yat-sen UniversityCancer center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)