Lung CancerPhase 2NCT00004137
S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing filgrastim, carboplatin and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 85 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. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a… 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?
- filgrastim, carboplatin and paclitaxel
- How many people
- 88 participants
- Where
- 85 sitesUnited States
- Study dates
- Oct 1999to Nov 2008
- Phase
- Phase 2
- 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 proven, previously untreated extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR Previously treated with radiotherapy and/or surgery Measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and recovered
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
United States85 sites
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
CCOP - Columbus
Columbus, Ohio, 43206
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
CCOP - Central Illinois
Decatur, Illinois, 62526
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
University of Colorado Cancer Center
Denver, Colorado, 80262
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of Texas Medical Branch
Galveston, Texas, 77555-0209
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
CCOP - Dayton
Kettering, Ohio, 45429
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
Texas Tech University Health Science Center
Lubbock, Texas, 79423
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153
MBCCOP - Gulf Coast
Mobile, Alabama, 36652
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center
Orange, California, 92868
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
Oregon Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Program
Portland, Oregon, 97213
University of California Davis Medical Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center
Tucson, Arizona, 85724
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer
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 may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.
- Conditions
- Lung Cancer
- Being tested
- filgrastim, carboplatin, paclitaxel, topotecan hydrochloride
- Keywords
- extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study startOct 1999
- Primary completionMar 2004
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 SWOG Cancer Research NetworkThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank Dunphy, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004137
- Sponsor's protocol ID
- CDR0000067367
- Other IDs
- S9914, U10CA032102
- Status last verified
- Feb 2013
- First submitted
- 10 Dec 1999
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hesketh PJ, McCoy J, Dunphy FR 2nd, Bearden JD 3rd, Weiss GR, Giguere JK, Atkins JN, Dakhil SR, Kelly K, Crowley JJ, Gandara DR. Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: Southwest Oncology Group 9914. J Thorac Oncol. 2006 Nov;1(9):991-5.
PubMed 17409984Dunphy F, Hesketh P, Chansky K, et al.: Southwest Oncology Group trial (SWOG) 9914: phase II trial of paclitaxel, carboplatin and topotecan (PCT) in untreated patients (pts) with extensive small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1184, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00004137
- Acronym / sponsor ID
- CDR0000067367
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Mar 2004 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 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. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.
OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| 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 15 Feb 2013.
- Results publication: PubMed 17409984Hesketh PJ, McCoy J, Dunphy FR 2nd, Bearden JD 3rd, Weiss GR, Giguere JK, Atkins JN, Dakhil SR, Kelly K, Crowley JJ, Gandara DR. Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: Southwest Oncology Group 9914. J Thorac Oncol. 2006 Nov;1(9):991-5.
- Results publicationDunphy F, Hesketh P, Chansky K, et al.: Southwest Oncology Group trial (SWOG) 9914: phase II trial of paclitaxel, carboplatin and topotecan (PCT) in untreated patients (pts) with extensive small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1184, 2002.
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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.
Frank Dunphy, MD study chair
Duke Cancer Institute
85 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, carboplatin and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 85 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00004137, which also lists 2 linked publications.
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 15 Feb 2013.