NCT00016341

Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in treating endometrial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer.

Detailed description

OBJECTIVES: * 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 months.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	doxorubicin hydrochloride
DRUG	megestrol acetate
DRUG	paclitaxel
DRUG	tamoxifen citrate

Timeline

• Start date: 2001-05-01
• Primary completion: 2003-10-01
• First posted: 2003-09-09
• Last updated: 2013-04-11

Locations

50 sites across 2 countries: United States, Canada