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Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01998347
Recruitment Status : Withdrawn (slow enrollment)
First Posted : November 28, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Lin Yingcheng, Shantou University Medical College

Brief Summary:
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Paclitaxel liposome Drug: Cisplatin Drug: 5-fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.
Study Start Date : November 2013
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paclitaxel liposome and Cisplatin

Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles.

Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.

Drug: Paclitaxel liposome
Drug: Cisplatin
Active Comparator: Cisplatin plus 5-fluorouracil

Cisplatin:

37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles.

5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.

Drug: Cisplatin
Drug: 5-fluorouracil



Primary Outcome Measures :
  1. median overall survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. median progression free survival [ Time Frame: 6 months ]

Other Outcome Measures:
  1. time to progression [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
  • At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
  • Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
  • Patients with performance status(ECOG) 0 to 1.
  • Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
  • Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl
  • Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases)
  • Life expectancy ≥ 3 months
  • Patients who have given written informed consent to participate in this study

Exclusion Criteria:

  • Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
  • Patients with brain metastasis
  • Patients receiving continuous administration of steroids
  • Patients who have experienced serious drug allergy in the past
  • Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
  • Patients who are pregnant and lactating or hope to become pregnant during the study period
  • Patients with prior Taxane treatment (Paclitaxel)
  • Others, patients judged by the investigator or coinvestigator to be inappropriate as subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998347


Locations
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China, Guangdong
Department of medical oncology,Cancer hospital of Shantou University Medical colledge
Shantou, Guangdong, China, 515031
Sponsors and Collaborators
Shantou University Medical College

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Responsible Party: Lin Yingcheng, deputy secretary, Shantou University Medical College
ClinicalTrials.gov Identifier: NCT01998347     History of Changes
Other Study ID Numbers: CSMECS 01
LYC01 ( Other Identifier: ShantouUMC )
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs