Gastric Cancer Clinical Trial
Official title:
Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II
Verified date | June 2012 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have metastatic or recurrent cancer of the esophagus.
Status | Completed |
Enrollment | 61 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction - Squamous cell carcinoma OR - Adenocarcinoma - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 to 100 Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: - No uncontrolled hypertension - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction within the past 6 months - No serious uncontrolled cardiac arrhythmia Gastrointestinal: - No active inflammatory bowel disease - No significant bowel obstruction - No chronic diarrhea Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No active infection requiring systemic therapy - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 28 days since prior biologic therapy - No prior biologic therapy for metastatic or recurrent disease - No concurrent sargramostim (GM-CSF) - No concurrent immunotherapy for tumor Chemotherapy: - At least 28 days since prior chemotherapy - No prior chemotherapy for metastatic or recurrent disease - No prior gemcitabine or irinotecan - Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed - No other concurrent chemotherapy for tumor Endocrine therapy: - See Disease Characteristics - At least 28 days since prior endocrine therapy - No prior endocrine therapy for metastatic or recurrent disease - No concurrent hormonal therapy for tumor Radiotherapy: - At least 28 days since prior radiotherapy - No prior radiotherapy for metastatic or recurrent disease - Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed - No concurrent radiotherapy for tumor Surgery: - Prior thoraco-abdominal surgery allowed - At least 3 weeks since prior surgery and recovered Other: - No other concurrent anti-cancer therapy for tumor |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Medical Center - Albany | Albany | New York |
United States | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico |
United States | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina |
United States | MBCCOP - University of Illinois at Chicago | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio |
United States | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Veterans Affairs Medical Center - Detroit | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Veterans Affairs Medical Center - Houston | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri |
United States | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi |
United States | CCOP - Dayton | Kettering | Ohio |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California |
United States | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
United States | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma |
United States | Chao Family Comprehensive Cancer Center | Orange | California |
United States | CCOP - Greater Phoenix | Phoenix | Arizona |
United States | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | OHSU Cancer Institute | Portland | Oregon |
United States | Veterans Affairs Medical Center - Portland | Portland | Oregon |
United States | University of Rochester Medical Center | Rochester | New York |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | University of California Davis Medical Center | Sacramento | California |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | Veterans Affairs Medical Center - Seattle | Seattle | Washington |
United States | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana |
United States | Providence Hospital - Southfield | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Veterans Affairs Medical Center - Temple | Temple | Texas |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
United States | MBCCOP-Howard University Cancer Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Veterans Affairs Medical Center - Wichita | Wichita | Kansas |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Williamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, Atkins JN, Blanke CD, Abbruzzese JL; Southwest Oncology Group (SWOG). Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-month survival rate | To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen. | 6 months after registration | No |
Secondary | Toxicities | To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study. | Week 1 and Week 2 of each cycle | Yes |
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