A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial cancer meeting the following criteria:

- Any of the following subtypes are allowed:

- Endometrioid

- Serous

- Clear cell

- Squamous/adenosquamous

- Undifferentiated

- Mixed histology

- All of the following disease stages are allowed:

- Stage IIIA disease

- Stage IIIC disease with positive cytologic washings/ascites, adnexal
spread, or serosal involvement

- Stage IV disease (by virtue of intraperitoneal disease spread)

- Prior total abdominal hysterectomy, bilateral salpingo-oophorectomy by either
laparotomy or laparoscopic assisted techniques

- Intraperitoneal and bulky nodal disease debulked to ≤ 2 cm gross maximal
residual margins

- No metastatic disease involving lung or liver parenchyma, bone, or inguinal or
scalene lymph nodes

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 2 mg/dL OR creatinine clearance > 50 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Neuropathy (sensory and motor) ≤ grade 1

- Ejection fraction normal

- No concurrent medical illness (e.g., serious uncontrolled infection, uncontrolled
angina, or serious peripheral neuropathy), which in the opinion of the treating
physician, makes the protocol treatments hazardous to the patient

- No third degree or complete heart block (unless a pacemaker is in place)

- Patients with other cardiac conduction abnormalities may be placed on study at
the discretion of the investigator

- No history of other invasive malignancies, except nonmelanoma skin cancer or evidence
of other malignancy present within the past 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 8 weeks since prior surgery

- Patients who are on medications which alter cardiac conduction (i.e., digitalis, beta
blockers, or calcium channel blockers) may be placed on study at the discretion of
the investigator

- No prior cancer treatment that contraindicates this protocol therapy

- No prior radiotherapy or chemotherapy for endometrial cancer at high risk for
peritoneal failure

- No concurrent prophylactic filgrastim/pegfilgrastim during intraperitoneal portion of
treatment (i.e., courses 3-6).