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Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084487
First received: June 10, 2004
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
 Drug: becatecarin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer

Resource links provided by NLM:

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate estimated as the proportion of responders [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    An exact binomial 95% confidence interval will be calculated for this proportion.

  • Event free survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Will be analyzed using Kaplan-Meier curves.

  • Overall survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Will be analyzed using Kaplan-Meier curves.


Enrollment: 39
Study Start Date: April 2004
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (becatecarin)
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
 Drug: becatecarin
Given IV
Other Names:
  • BMS-181176
  • rebeccamycin analogue
  • rebeccamycin analogue, tartrate salt
  • XL119

Detailed Description:

OBJECTIVES:

I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.

II. Determine the duration of remission and survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of small cell lung cancer (SCLC)

    • Limited or extensive stage
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Sensitive* relapsed disease after only 1 prior chemotherapy regimen

  • Brain metastasis allowed provided the following criteria are met:

    • Stable brain disease
    • Not receiving irradiation
    • No steroid requirement to control symptoms
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
  • Bilirubin ≤ 1.5 mg/dL
  • Creatinine < 2.0 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • No New York Heart Association class III or IV heart disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • See Disease Characteristics
  • See Disease Characteristics
  • See Disease Characteristics
  • Prior radiotherapy allowed
  • No other concurrent investigational agents
  • No other concurrent therapies for SCLC
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084487

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Afshin Dowlati Case Western Reserve University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084487     History of Changes
Other Study ID Numbers: NCI-2012-02587, CASE-CWRU-1503, U01CA062502
Study First Received: June 10, 2004
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013