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

NCT00754858 | Completed Phase 2

• 4 other identifiers: CDR0000614308YONSEI-4-2008-0127CKDPC-YONSEI-4-2008-0127YONSEI-07-YUHS-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

belotecan and Cisplatin

EXPERIMENTAL

belotecan 0.5 mg/m2 and Cisplatin 60mg/m2

Drug: belotecan hydrochloride; Drug: cisplatin

Interventions

belotecan hydrochloride DRUG

belotecan and Cisplatin

cisplatin DRUG

belotecan and Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

belotecan; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

KR (1)