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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

belotecan hydrochloride

cisplatin

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yonsei Cancer Center at Yonsei University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

belotecan and Cisplatin

Arm Description

belotecan 0.5 mg/m2 and Cisplatin 60mg/m2

Outcomes

Primary Outcome Measures

Response rate as assessed by RECIST criteria

Overall survival

Progression-free survival

Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0

Secondary Outcome Measures

Full Information

NCT ID

NCT00754858

First Posted

September 17, 2008

Last Updated

November 26, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT00754858

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

extensive stage small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

belotecan and Cisplatin

Arm Type

Experimental

Arm Description

belotecan 0.5 mg/m2 and Cisplatin 60mg/m2

Intervention Type

Drug

Intervention Name(s)

belotecan hydrochloride

Intervention Type

Drug

Intervention Name(s)

cisplatin

Primary Outcome Measure Information:

Title

Response rate as assessed by RECIST criteria

Time Frame

21days(1cycle)

Title

Overall survival

Time Frame

21days(1cycle)

Title

Progression-free survival

Time Frame

21days(1cycle)

Title

Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0

Time Frame

21days(1cycle)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo-Hang Kim, MD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei Cancer Center at Yonsei University Medical Center

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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