NCT00006017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started May 2000

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

3.2 years

First QC Date

July 5, 2000

Last Update Submit

June 9, 2010

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Rebeccamycin 1 day

ACTIVE COMPARATOR

Patients receive rebeccamycin analogue IV over 1 hour on day 1.

Drug: becatecarin

Rebeccamycin 5 day

ACTIVE COMPARATOR

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5.

Drug: becatecarin

Interventions

becatecarinDRUG

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.

Also known as: DEAE-rebeccamycin, rebeccamycin analogue, rebeccamycin analogue, tartrate salt
Rebeccamycin 1 dayRebeccamycin 5 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

becatecarin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Afshin Dowlati, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

July 1, 2003

Study Completion

January 1, 2005

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(2)