Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754858
• Other study ID #: CDR0000614308
• Secondary ID: YONSEI-4-2008-01
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2008
• Last updated: November 26, 2014
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.

Description:

OBJECTIVES:

Primary

• To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer.

Secondary

• To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients.

• To determine the safety and tolerability of this drug combination in these patients.

OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer meeting the following criteria:

• Extensive-stage disease

• Previously untreated disease

• At least one measurable disease

• No brain or leptomeningeal metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 12 weeks

• ANC = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 9.0 g/dL

• Total bilirubin = 1.5 mg/dL

• ALT and AST = 2.0 times upper normal limit (ULN) (= 5.0 times ULN in the presence of liver metastasis)

• Alkaline phosphatase = 2.0 times ULN

• Creatinine = 1.5 mg/dL OR creatinine clearance = 60 mL/min

• No active infection requiring intravenous antibiotics

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer

• No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No other concurrent chemotherapy, radiotherapy, or immunotherapy

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• belotecan hydrochloride

• cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as assessed by RECIST criteria		21days(1cycle)	Yes
Primary	Overall survival		21days(1cycle)	Yes
Primary	Progression-free survival		21days(1cycle)	Yes
Primary	Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0		21days(1cycle)	Yes