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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
Not Enrolling
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


- 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

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


- 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



- Not specified

Performance status:

- SWOG 0-1

Life expectancy:

- Not specified


- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


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

- SGOT or SGPT ≤ 2 times ULN


- Creatinine clearance ≥ 50 mL/min


- 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


- 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

- 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


Biologic therapy:

- No prior immunotherapy for ovarian cancer


- No prior chemotherapy for ovarian cancer

Endocrine therapy:

- Not specified


- No prior pelvic radiotherapy for ovarian cancer


- See Disease Characteristics

- Recovered from all reversible surgery-related toxic effects


- No other concurrent antitumor treatment

- No concurrent antibiotics for infection of undetermined etiology

Type of Study:


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:


Principal Investigator

Harriet O. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Federal Government

Study ID:




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



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