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Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer


OBJECTIVES:

- Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV
doxorubicin HCl liposome, in terms of progression-free survival and overall survival,
in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or
primary peritoneal cancer.

- Determine the feasibility of and toxic effects associated with this regimen in these
patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over
30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl
liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive
paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary
peritoneal carcinoma

- Tumor involves one or both ovaries with microscopically confirmed peritoneal
metastasis outside the pelvis and/or regional lymph node metastasis

- No tumors of borderline or low malignant potential only

- Mixed Mullerian tumors allowed

- Must have optimal disease defined as no residual lesions after resection or residual
disease such that no single lesion measures greater than 1 cm in diameter

- Must have undergone staging exploratory laparotomy with tumor debulking within the
past 70 days

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- SWOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic:

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2 times ULN

Renal:

- Creatinine clearance ≥ 50 mL/min

Cardiovascular:

- No congestive heart failure

- No cardiac arrhythmia

- No myocardial infarction or unstable angina within the past 6 months

- Patients with a history of myocardial disease must not have ischemia or pathologic
arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No active or uncontrolled infection

- No concurrent fever

- No grade 2 or greater sensory neuropathy

- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding,
diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection

- No erythema or tenderness of abdominal incision or port site suggestive of underlying
infection

- No other malignancy within the past five years except adequately treated basal cell
or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy for ovarian cancer

Chemotherapy:

- No prior chemotherapy for ovarian cancer

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior pelvic radiotherapy for ovarian cancer

Surgery:

- See Disease Characteristics

- Recovered from all reversible surgery-related toxic effects

Other:

- No other concurrent antitumor treatment

- No concurrent antibiotics for infection of undetermined etiology

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.

Outcome Time Frame:

Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.

Safety Issue:

No

Principal Investigator

Harriet O. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067066

NCT ID:

NCT00003896

Start Date:

September 1999

Completion Date:

February 2008

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Montana Cancer Consortium Billings, Montana  59101
Harrington Cancer Center Amarillo, Texas  79106
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Northwest Tacoma, Washington  98405-0986
Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
University of California Davis Cancer Center Sacramento, California  95817
Wesley Medical Center Wichita, Kansas  67214
City of Hope Comprehensive Cancer Center Duarte, California  91010
Great Falls Clinic Great Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
St. Luke's Mountain States Tumor Institute - Boise Boise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth Campus Grand Rapids, Michigan  49503-2560
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Kingman Kingman, Kansas  67068
Southwest Medical Center Liberal, Kansas  67901
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Parsons Parsons, Kansas  67357
Pratt Cancer Center of Kansas Pratt, Kansas  67124
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. Wichita, Kansas  67208
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Wichita Wichita, Kansas  67214
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Mecosta County General Hospital Big Rapids, Michigan  49307
Metropolitan Hospital Grand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical Center Grand Rapids, Michigan  49503
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Northern Michigan Hospital Petoskey, Michigan  49770
Munson Medical Center Traverse City, Michigan  49684
St. Francis Medical Center Cape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Deaconess Billings Clinic Cancer Center Billings, Montana  59107
Internal Medicine Associates of Bozeman Bozeman, Montana  59715
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
Sletten Regional Cancer Institute Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Eastern Montana Cancer Center Miles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Central Washington Hospital Wenatchee, Washington  98801
Wenatchee Valley Clinic Wenatchee, Washington  98801
Welch Cancer Center Sheridan, Wyoming  82801
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Summit Medical Center Oakland, California  94609
Saint Rose Hospital Hayward, California  94545
J.C. Robinson, M.D. Regional Cancer Center San Pablo, California  94806
Salina Regional Health Center Salina, Kansas  67401
Bay Regional Medical Center Bay City, Michigan  48708
Doctor's Hospital of Laredo Laredo, Texas  78041
Danville Regional Medical Center Danville, Virginia  24541
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Capital Medical Center Olympia, Washington  98502
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Valley Memorial Hospital Livermore, California  94550
Highland General Hospital Oakland, California  94602
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Spectrum Health Hospital - Blodgett Campus Grand Rapids, Michigan  49506
Mercy Hospital Port Huron, Michigan  48060
Salem Hospital Regional Cancer Center Salem, Oregon  97309
Cancer Care Center at Skagit Valley Hospital Mt. Vernon, Washington  98273
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Care Center at Battle Creek Health System Battle Creek, Michigan  49017
Judy L. Schmidt, MD, FACP, P. C. Missoula, Montana  59804
Good Samaritan Health Systems Kearney, Nebraska  68847
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
Providence Hospital Centralia, Washington  98531