Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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Purpose
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 irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer |
| Enrollment: | 2 |
| Study Start Date: | April 2003 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: irinotecan
irinotecan
|
Drug: irinotecan
Other Name: camptosar
|
Detailed Description:
OBJECTIVES:
- Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan.
- Determine the progression-free and overall survival of patients treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- No mixed mullerian and borderline ovarian tumors
- Surgically staged as stage III or IV at initial diagnosis
Must meet one of the following criteria for refractory/relapsed disease:
- Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy
Had a best response of increasing disease during this front-line regimen
- Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen
Unidimensionally measurable disease
- At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
- At least 1 cm by spiral CT scan
- Measurable disease must remain outside of radiotherapy field
- If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No myocardial infarction within the past 6 months
- No angina pectoris
- No uncontrolled congestive heart failure
- No uncontrolled cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No other malignancy within the past 5 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No more than 1 prior biological response modifier
- At least 28 days since prior biological response modifier and recovered
Chemotherapy
- See Disease Characteristics
- No prior topotecan or other topoisomerase I inhibitor
- One other additional prior chemotherapy regimen allowed
- At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered
Endocrine therapy
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy
- At least 28 days since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent palliative radiotherapy
Surgery
- At least 14 days since prior major surgery and recovered
Other
- At least 28 days since prior investigational drugs and recovered
- No other concurrent antitumor therapy
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock (McClellan) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| California Cancer Center | |
| Fresno, California, United States, 93720 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813-2424 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-W227 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| United States, Mississippi | |
| Veterans Affairs Medical Center - Biloxi | |
| Biloxi, Mississippi, United States, 39531-2410 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at the University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97225 | |
| Oregon Cancer Institute | |
| Portland, Oregon, United States, 97201-3098 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4095 | |
| Veterans Affairs Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78229 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Study Chair: | Amy D. Tiersten, MD | New York University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00053833 History of Changes |
| Other Study ID Numbers: | CDR0000269486, S0025, U10CA032102 |
| Study First Received: | February 5, 2003 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013