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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003120
Other study ID # CDR0000065875
Secondary ID SWOG-S9701GOG-17
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated October 7, 2014
Start date November 1997
Est. completion date November 2012

Study information

Verified date October 2014
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.


Description:

OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.


Recruitment information / eligibility

Status Completed
Enrollment 308
Est. completion date November 2012
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial laparotomy Must have attained a clinically defined complete remission (CR) following treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination chemotherapy regimen by achieving the following: No evidence of cancer on physical examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must register for study within 21 to 56 days after prior chemotherapy Not concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment phase III GOG trials

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look laparotomy or laparoscopy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
paclitaxel
135 mg/m2 IV every 28 days

Locations

Country Name City State
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 MBCCOP - University of Illinois at Chicago Chicago Illinois
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University 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 - Dallas Dallas Texas
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 Cancer Center and Beckman Research Institute, City of Hope 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 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 Scripps Clinic Cancer Center La Jolla California
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 Veterans Affairs Medical Center - Long Beach Long Beach California
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 Texas Tech University Health Science Center Lubbock Texas
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 Veterans Affairs Medical Center - New Orleans 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 (Hayden) Phoenix Arizona
United States CCOP - Columbia River Program Portland Oregon
United States Oregon Cancer Center Portland Oregon
United States Veterans Affairs Medical Center - Portland Portland Oregon
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 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
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 CCOP - Wichita Wichita Kansas
United States Veterans Affairs Medical Center - Wichita Wichita Kansas
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Liu P, Moon J, Alberts DS, et al.: A modified CA-125 progression criterion in ovarian cancer (OC) patients (pts) receiving maintenance treatment following complete clinical response (cCR) to primary therapy. [Abstract] J Clin Oncol 24 (Suppl 18): A-5080,

Liu PY, Alberts DS, Monk BJ, et al.: Relationship between pretreatment CA-125 level and risk of relapse in advanced ovarian cancer (AOC) patients in a complete clinical response (CCR) who received "maintenance therapy". [Abstract] J Clin Oncol 23 (Suppl 16): A-5013, 458s, 2005.

Markman M, Liu P, Wilczynski S, et al.: Survival (S) of ovarian cancer (OC) patients (pts) treated on SWOG9701/GOG178: 12 versus (v) 3 cycles (C) of monthly single-agent paclitaxel (PAC) following attainment of a clinically-defined complete response (CR)

Markman M, Liu PY, Rothenberg ML, Monk BJ, Brady M, Alberts DS. Pretreatment CA-125 and risk of relapse in advanced ovarian cancer. J Clin Oncol. 2006 Mar 20;24(9):1454-8. — View Citation

Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer — View Citation

Markman M. Maintenance chemotherapy in advanced ovarian cancer: the US experience. Int J Gynecol Cancer. 2008 Mar-Apr;18 Suppl 1:40-3. doi: 10.1111/j.1525-1438.2007.01104.x. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary progression-free survival duration between date of enrollment and date first recurrence or death due to any cause. No
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