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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 CenterSeattle, Washington  98109
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Harrington Cancer CenterAmarillo, Texas  79106
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - NorthwestTacoma, Washington  98405-0986
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
St. Francis Medical CenterCape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Welch Cancer CenterSheridan, Wyoming  82801
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Summit Medical CenterOakland, California  94609
Saint Rose HospitalHayward, California  94545
J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California  94806
Salina Regional Health CenterSalina, Kansas  67401
Bay Regional Medical CenterBay City, Michigan  48708
Doctor's Hospital of LaredoLaredo, Texas  78041
Danville Regional Medical CenterDanville, Virginia  24541
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Valley Memorial HospitalLivermore, California  94550
Highland General HospitalOakland, California  94602
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Spectrum Health Hospital - Blodgett CampusGrand Rapids, Michigan  49506
Mercy HospitalPort Huron, Michigan  48060
Salem Hospital Regional Cancer CenterSalem, Oregon  97309
Cancer Care Center at Skagit Valley HospitalMt. Vernon, Washington  98273
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Care Center at Battle Creek Health SystemBattle Creek, Michigan  49017
Judy L. Schmidt, MD, FACP, P. C.Missoula, Montana  59804
Good Samaritan Health SystemsKearney, Nebraska  68847
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Providence HospitalCentralia, Washington  98531