Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yonsei University
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00754858
First received: September 17, 2008
Last updated: March 12, 2009
Last verified: December 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: belotecan hydrochloride Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-Stage Small-Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 46 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754858
Locations
| Korea, Republic of | |
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Joo-Hang Kim, MD 82-2-2228-8131 kjhang@yuhs.ac | |
Sponsors and Collaborators
Yonsei University
Investigators
| Principal Investigator: | Joo-Hang Kim, MD | Yonsei University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00754858 History of Changes |
| Other Study ID Numbers: | CDR0000614308, YONSEI-4-2008-0127, CKDPC-YONSEI-4-2008-0127, YONSEI-07-YUHS-02 |
| Study First Received: | September 17, 2008 |
| Last Updated: | March 12, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
extensive stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Belotecan Cisplatin |
Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013