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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: cisplatin; Drug: belotecan hydrochloride

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei Cancer Center at Yonsei University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: belotecan and Cisplatin; belotecan 0.5 mg/m2 and Cisplatin 60mg/m2	Drug: cisplatin; Drug: belotecan hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate as assessed by RECIST criteria	21days(1cycle)
Overall survival	21days(1cycle)
Progression-free survival	21days(1cycle)
Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0	21days(1cycle)

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Joo-Hang Kim, MD, Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: extensive stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Cisplatin; Belotecan
• Other Study ID Numbers: CDR0000614308; YONSEI-4-2008-0127; CKDPC-YONSEI-4-2008-0127; YONSEI-07-YUHS-02