Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006017
First received: July 5, 2000
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: becatecarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue [ Time Frame: via 1 infusion vs 5 daily infusions every 3 weeks. ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: May 2000
Study Completion Date: January 2005
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rebeccamycin 1 day
Patients receive rebeccamycin analogue IV over 1 hour on day 1.
Drug: becatecarin
Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Other Names:
  • DEAE-rebeccamycin
  • rebeccamycin analogue
  • rebeccamycin analogue, tartrate salt
Active Comparator: Rebeccamycin 5 day
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5.
Drug: becatecarin
Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Other Names:
  • DEAE-rebeccamycin
  • rebeccamycin analogue
  • rebeccamycin analogue, tartrate salt

Detailed Description:

OBJECTIVES:

  • Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks.
  • Compare the response duration in patients treated with these regimens.
  • Compare the toxicity profiles of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1.
  • Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage IIIB (with pleural effusions), IV, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT less than 2 times normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent combination antiretroviral therapy for HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006017

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Afshin Dowlati, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006017     History of Changes
Other Study ID Numbers: CWRU1599, U01CA063200, P30CA043703, CWRU-1599, NCI-91
Study First Received: July 5, 2000
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014