NCT00003154

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Jan 1998

Geographic Reach
1 country

1 active site

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

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

3.2 years

First QC Date

November 1, 1999

Last Update Submit

June 9, 2010

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

    120 hour continuous infusion once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy.

Interventions

aminocamptothecin colloidal dispersionDRUG

120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed measurable stage IIIB or IV non-small cell lung cancer No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Calcium and electrolytes normal Other: No other malignancy within past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing No active infections or other serious medical conditions PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy No prior radiotherapy to site(s) of measurable disease Surgery: At least 3 weeks since any prior surgery

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

Sponsors & Collaborators

Study Sites (1)

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nathan Levitan, 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 19, 2004

Study Start

January 1, 1998

Primary Completion

April 1, 2001

Study Completion

June 1, 2001

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(1)