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Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
Ulsan University Hospital
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01022671
First received: November 26, 2009
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: Belotecan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: every 2 cyc ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 6 months after Last patient out ] [ Designated as safety issue: No ]
  • Progression Free survival [ Time Frame: 6 months after Last patient out ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: every visit ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belotecan
Single arm
 Drug: Belotecan
3.0 mg/m2, Day 1, 8, 15 every 4 weeks
Other Name: Camtobell inj.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 Years and older
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)
  • ≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
  • prior platinum based chemotherapy
  • ECOG PS ≤ 2
  • Life expectancy > 3 months

  • Adequate organ function:

    • hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL
    • hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN
    • renal: serum creatinine ≤ 1.5×ULN
  • Signed a written informed consent

Exclusion Criteria:

  • Active infection
  • Symptomatic brain lesion
  • Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • Severe concurrent diseases
  • Prior anticancer therapy within 4 weeks before enroll
  • Active pregnancy test
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01022671     History of Changes
Other Study ID Numbers: 11NSCLC08K
Study First Received: November 26, 2009
Last Updated: August 8, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Chong Kun Dang Pharmaceutical:
Belotecan
Camtobell inj
NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Belotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013