Expired Study
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Tampa, Florida 33612


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm^3 - Granulocyte count at least 1,500/mm^3 Hepatic: - Bilirubin normal - SGPT no greater than 3 times upper limit of normal Renal: - Creatinine no greater than 1.6 mg/dL Cardiovascular: - 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 discretion - No history of deep venous thrombosis - No uncontrolled angina Pulmonary: - No history of pulmonary embolus Other: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy allowed Chemotherapy: - No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization Endocrine therapy: - No prior hormonal therapy for endometrial cancer Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine Surgery: - See Disease Characteristics Other: - Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion


Study is Available At:


Original ID:

CDR0000068624


NCT ID:

NCT00016341


Secondary ID:

GOG-0189


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Primary Purpose: Treatme


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Jeffrey D. Bloss, MD
Study Chair
Washington University Siteman Cancer Center

Study Dates

Start Date:May 2001
Primary Completion Date:October 2003
Primary Completion Type:Actual
Verification Date:June 2007
Last Changed Date:April 10, 2013
First Received Date:May 6, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:cisplatin
Intervention Type:Drug
Name:doxorubicin hydrochloride
Intervention Type:Drug
Name:megestrol acetate
Intervention Type:Drug
Name:paclitaxel
Intervention Type:Drug
Name:tamoxifen citrate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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