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

Sponsor:	Taian Cancer Hospital
Information provided by:	Taian Cancer Hospital
ClinicalTrials.gov Identifier:	NCT01034683

Purpose

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	Intervention	Phase
Esophageal Carcinoma	Drug: lobaplatin , 5-FU ,leucovorin	Phase III

Study Type:	Interventional
Study Design:	Control: Uncontrolled Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor D 19466 Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Taian Cancer Hospital:

Primary Outcome Measures:

objective response rate(ORR) time to progression (TTP) toxicities [ Time Frame: 12/31/2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1-year survival rate KPS score [ Time Frame: 12/31/2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Esophageal Carcinoma: Experimental	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034683

Locations

China, Shandong
Taian Cancer Hospital
Taian, Shandong, China, 271000

Sponsors and Collaborators

Taian Cancer Hospital

Investigators

Study Chair:

Lin Guan

Taian Cancer Hospital

More Information

No publications provided

Responsible Party:	Taian Cancer Hospital ( Taian Cancer Hospital )
ClinicalTrials.gov Identifier:	NCT01034683 History of Changes
Other Study ID Numbers:	TACH2009001
Study First Received:	December 16, 2009
Last Updated:	January 4, 2010
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma

Esophageal Diseases

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms

Gastrointestinal Diseases

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms by Site

Head and Neck Neoplasms

Fluorouracil

Leucovorin

Antimetabolites, Antineoplastic

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions

Antineoplastic Agents

Therapeutic Uses

Immunosuppressive Agents

Immunologic Factors

Physiological Effects of Drugs

Vitamin B Complex

Vitamins

Micronutrients

Growth Substances

ClinicalTrials.gov processed this record on September 06, 2010