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Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT01034683
Recruitment Status : Unknown
Verified December 2009 by Taian Cancer Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
Taian Cancer Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Drug: lobaplatin , 5-FU ,leucovorin Phase 3

Detailed Description:
patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Esophageal Carcinoma Drug: lobaplatin , 5-FU ,leucovorin
Participants received 2-hour lobaplatin (30 mg/m2 on day 1) and a 2-hour infusion of leucovorin (LV; 200 mg/m2 on days 1-5) followed by a 4-hour infusion of 5-FU (650 mg/m2 on days 1-5). Treatment was repeated every 21 days.
Other Name: LBP ,5-FU,LV


Outcome Measures
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Primary Outcome Measures :
  1. objective response rate(ORR) time to progression (TTP) toxicities [ Time Frame: 12/31/2010 ]

Secondary Outcome Measures :
  1. 1-year survival rate KPS score [ Time Frame: 12/31/2009 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
  • Newly diagnosed patients should be unable or unwilling to surgery
  • Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
  • Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm.
  • Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months
  • Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L
  • Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN
  • Serum creatinine (Cr)≤1.5ULN

Exclusion Criteria:

  • pregnant or nursing women;
  • Female patients at child-bearing age, without taking effective contraceptive methods;
  • patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
  • patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
  • patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard >grade 2
  • patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / L
Contacts and Locations
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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): NCT01034683


Locations
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China, Shandong
Taian Cancer Hospital
Taian, Shandong, China, 271000
Sponsors and Collaborators
Taian Cancer Hospital
Investigators
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Study Chair: Lin Guan Taian Cancer Hospital
More Information
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Responsible Party: Taian Cancer Hospital
ClinicalTrials.gov Identifier: NCT01034683     History of Changes
Other Study ID Numbers: TACH2009001
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: December 2009
Additional relevant MeSH terms:
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Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs