NCT00006082

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 nitrocamptothecin in treating patients who have advanced small cell lung cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2 lung-cancer

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

May 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

August 3, 2000

Last Update Submit

September 20, 2012

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Interventions

rubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen * Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR * Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy * Minimum of 1 target lesion that can be accurately measured in at least 1 dimension * 20 mm or more with conventional techniques OR * 10 mm or more with spiral CT scans * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present) Renal: * Creatinine no greater than 1.7 mg/dL Cardiovascular: * No ischemic heart disease within the past 6 months * Normal 12 lead electrocardiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer * No unstable systemic disease or active uncontrolled infection * No psychological, familial, sociological, or geographical condition that may preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior maintenance therapy with biologic agents following first line chemotherapy allowed * No concurrent filgrastim (G-CSF) with nitrocamptothecin Chemotherapy: * See Disease Characteristics * Greater than 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen for extensive disease * Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Greater than 4 weeks since prior radiotherapy Surgery: * Greater than 2 weeks since prior major surgery Other: * No other concurrent anticancer therapy * No other concurrent investigational therapy

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

Sponsors & Collaborators

Study Sites (1)

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

rubitecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

May 22, 2003

Study Start

May 1, 2000

Primary Completion

August 1, 2002

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(1)