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

Esophageal Carcinoma Clinical Trial

Official title:

Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01034683
• Other study ID #: TACH2009001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: January 4, 2010
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: Taian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Taian Cancer Hospital	Taian	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Taian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate(ORR) time to progression (TTP) toxicities		12/31/2010	Yes
Secondary	1-year survival rate KPS score		12/31/2009	Yes