NCT00025272

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and etoposide in treating patients who have extensive-stage small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Nov 2001

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

October 11, 2001

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2005

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

October 11, 2001

Last Update Submit

September 7, 2021

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (3)

  • Duration of response

  • Failure-free and overall survival

  • Pharmacokinetics and pharmacodynamics of topotecan and etoposide

Interventions

carboplatinDRUG
etoposideDRUG
topotecan hydrochlorideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer * Measurable or evaluable disease * Pleural effusions allowed, but not considered measurable or evaluable disease * Brain metastases allowed provided neurologically stable at study entry PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 2 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow capsules * No concurrent or prior malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix * No other serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy for brain metastasis allowed * No other prior radiotherapy * No other concurrent radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (5)

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534-9479, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

CarboplatinEtoposideTopotecanRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • Antonius A. Miller, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

January 18, 2005

Study Completion

January 18, 2005

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(5)