Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016341
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2001-05-06
Brief Title:
Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent Stage III or Stage IV Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Randomized Phase III Crossover Trial of Chemotherapy DoxorubicinCisplatinPaclitaxel and G-CSF Versus Hormonal Therapy TamoxifenMegestrol Acetate in Patients With Stage III IV or Recurrent Endometrial Cancer
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 IPatients 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
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 IPatients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0189 | None | None | None |