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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as assessed by RECIST criteria

Safety Issue:

No

Principal Investigator

Joo-Hang Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University

Authority:

Unspecified

Study ID:

CDR0000614308

NCT ID:

NCT00754858

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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