Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma
-FIGO stage III or IV or recurrent disease
- Must know estrogen and progesterone status of the primary tumor
- Poor potential for curative treatment by radiotherapy and/or surgery
- At least 1 unidimensionally measurable lesion (for patients with stage III disease
only)
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, or MRI) OR at least 10 mm by spiral CT scan
- Disease in a previously irradiated field acceptable as the only site of
measurable disease only if there has been clear progression since completion of
radiotherapy
PATIENT CHARACTERISTICS:
AGE
- 18 and over PERFORMANCE STATUS
- GOG 0-2 LIFE EXPECTANCY
- Not specified HEMATOPOIETIC
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3 HEPATIC
- Bilirubin normal
- ALT no greater than 3 times upper limit of normal RENAL
- Creatinine no greater than 1.6 mg/dL CARDIOVASCULAR
- LVEF at least 50%
- Cardiac conduction abnormalities or dysfunction allowed at the investigator's
discretion
- No third-degree or complete heart block without a pacemaker
- No uncontrolled angina
- No myocardial infarction within the past 6 months
- No New York Heart Association class II -IV heart failure
- No symptoms of congestive heart failure OTHER
- Not pregnant or nursing
- Fertile patients must use effective non-hormonal contraception during and for at
least 2 months after study participation
- No other invasive malignancy within the past 5 years except patients who have
nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
- No serious uncontrolled infection
- No serious peripheral neuropathy
- No other concurrent medical illness that would preclude study therapy
- No circumstances that would preclude study completion or follow-up
- No sensitivity to Escherichia coli-derived drug preparations
- No uterine carcinosarcoma or other non-epithelial uterine malignancy
PRIOR CONCURRENT THERAPY:
BIOLOGIC THERAPY
- Prior biologic therapy allowed
- No concurrent biologic therapy CHEMOTHERAPY
- No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or
any other malignancy ENDOCRINE THERAPY
- Prior hormonal therapy allowed
- No concurrent hormonal therapy RADIOTHERAPY
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the
spine
- No concurrent radiotherapy SURGERY
- Not specified OTHER
- Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers,
or calcium channel blockers) are allowed at the investigator's discretion