Lung CancerPhase 3NCT00003917
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
A Phase 3 study testing topotecan hydrochloride in people with Lung Cancer, run by Case Comprehensive Cancer Center at 53 sites in United States.
Trial 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 if topotecan is more effective given by infusion or by mouth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- topotecan hydrochloride
- How many people
- 4 participants
- Where
- 53 sitesUnited States
- Study dates
- Mar 1999to Nov 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, 30912-3620
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Cooper Cancer Institute
Camden, New Jersey, 08103
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Oncology Clinic, P.C.
Colorado Springs, Colorado, 80909
Henry Ford Hospital
Detroit, Michigan, 48202
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Texas Cancer Care
Fort Worth, Texas, 76104
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
Shands Cancer Center
Gainesville, Florida, 32610
University of Texas Medical Branch
Galveston, Texas, 77555-0209
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Oncology and Hematology Associates, Inc.
Indianapolis, Indiana, 46219
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
Scripps Clinic
La Jolla, California, 92037
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
Central Pennsylvania Hematology & Medical Oncology Associates, PC
Lemoyne, Pennsylvania, 17043-1440
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
Joe Arrington Cancer Center
Lubbock, Texas, 79410
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
Alton Ochsner Medical Foundation Hospital
New Orleans, Louisiana, 70121
Office of Michael E. Lee
Norfolk, Virginia, 23502
Baptist Hospital- Pensacola
Pensacola, Florida, 32522
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
St. Joseph Mercy Hospital
Pontiac, Michigan, 48341-2985
Southwest Cancer Care
Poway, California, 92064
Brown University Oncology Group
Providence, Rhode Island, 02912
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Hematology & Oncology Associates of Virginia
Richmond, Virginia, 23226
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
Rochester General Hospital
Rochester, New York, 14621
University of California Davis Cancer Center
Sacramento, California, 95817
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
Sidney Kimmel Cancer Center
San Diego, California, 92121
Santa Fe Hematology/Oncology
Santa Fe, New Mexico, 87505
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
St. John's Mercy Medical Center
St Louis, Missouri, 63141
State University of New York - Upstate Medical University
Syracuse, New York, 13210
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Scott and White Memorial Hospital
Temple, Texas, 76508
Cooper Hospital/University Medical Center
Voorhees Township, New Jersey, 08043
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Salem Research
Winston-Salem, North Carolina, 27103
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy
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 if topotecan is more effective given by infusion or by mouth.
PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
Read the detailed description
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- topotecan hydrochloride
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2004 (estimated)
- Study startMar 1999
- Primary completionNov 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Smith Kline Beecham
- Responsible party
- Sponsor
- Investigators
- Nathan Levitan, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003917
- Sponsor's protocol ID
- SKF1598
- Other IDs
- CWRU-SKF-1598, SB-104864-A/396, NCI-G99-1524
- Status last verified
- Jan 2014
- First submitted
- 1 Nov 1999
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.
PubMed 17513814
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy
- ClinicalTrials.gov ID
- NCT00003917
- Acronym / sponsor ID
- SKF1598
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Smith Kline Beecham
- Study start
- Mar 1999
- Primary completion
- Nov 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 14 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 if topotecan is more effective given by infusion or by mouth.
PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
Detailed description
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Results publication: PubMed 17513814Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Levitan, MD study chair
Case Comprehensive Cancer Center
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topotecan hydrochloride in people with Lung Cancer, run by Case Comprehensive Cancer Center at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.