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Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer

Phase 3
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer


- Compare the progression-free survival and response of patients with stage III or IV or
recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and
filgrastim (G-CSF) vs tamoxifen and megestrol.

- Compare the survival of patients treated with these regimens.

- Determine if progesterone receptor status provides information on whether patients are
more likely to benefit from chemotherapy.

- Compare the toxicity profiles of these treatment regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified
according to progesterone receptor status (negative vs positive). Patients are randomized to
1 of 2 treatment arms.

- Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes
followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and
filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days.
Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease
progression or unacceptable toxicity.

- At time of disease progression, patients cross-over to hormonal therapy as in arm II.

- Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on
weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity.

At time of disease progression, if patients have not previously been enrolled on arm I,
patients cross-over to receive chemotherapy as in arm I.

Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6
weeks on cross-over therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42

Inclusion Criteria


- Histologically confirmed primary stage III or IV or recurrent endometrial cancer

- Poor curative potential with radiotherapy or surgery (alone or in combination)

- Measurable disease

- At least one lesion accurately measured in at least one dimension

- At least 20 mm by conventional techniques, including palpation, x-ray, CT
scan, or MRI OR

- At least 10 mm by spiral CT scan

- Disease in a previously irradiated field as sole site of measurable disease
allowed only if clear progression after completion of radiotherapy

- Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required

- ER/PR status of measurable tumor optional



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3


- Bilirubin normal

- SGPT no greater than 3 times upper limit of normal


- Creatinine no greater than 1.6 mg/dL


- LVEF at least 50%

- No third-degree or complete heart block, unless pacemaker is in place

- Other conduction abnormalities or cardiac dysfunction allowed at the investigator's

- No history of deep venous thrombosis

- No uncontrolled angina


- No history of pulmonary embolus


- No other malignancy within the past 5 years except nonmelanoma skin cancer

- No concurrent medical illness that would preclude study

- No serious uncontrolled infection

- No serious peripheral neuropathy

- No circumstances that would preclude study compliance

- No sensitivity to E. coli-derived drug preparations


Biologic therapy:

- Prior biologic therapy allowed


- No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization

Endocrine therapy:

- No prior hormonal therapy for endometrial cancer


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50%
of the spine


- See Disease Characteristics


- Concurrent cardiac conduction-altering medications such as digitalis, beta blockers,
or calcium channel blockers allowed at the investigator's discretion

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jeffrey D. Bloss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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