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Completed

NCT Number: NCT02861690

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Liposomal Paclitaxel

Drug

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

Nedaplatin

Drug

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

Primary outcomes

  1. Response rate

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

    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.

Secondary outcomes

  1. progression-free survival

    Time frame: 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

    Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.

  2. overall survival

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

    Overall survival is defined as the time from the date of study enrollment to the date of death from any cause.

  3. Number of Participants With Adverse Events (Toxicity)

    Time frame: Up to 30 days post last dose

    Number of participants with treatment-related adverse events as assessed by CTCAE.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Aug 10, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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