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Study Summary
No. GOG 0209:.......Endometrial......Lois M. Ramondetta......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
GOG 0209
Study Title:A Randomized Phase III Trial of Doxorubicin / Cisplatin / Paclitaxel / G-CSF versus Carboplatin / Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer
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Physician New Patient Referral
Name:Lois M. RamondettaPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-0307
Contact us about clinical trials
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General Information
Disease Group:EndometrialSupported By:Gynecologic Oncology Group (GOG)
Phase of Study:Phase IIIReturn
Visit:
Every 21 days x 7 cyclesfor treatment; Follow-up: q 3 months x 2 years,then q 6
months x 3 years, and annually thereafter.
Treatment
Agents:
Carboplatin
Cisplatin
Doxorubicin
Filgrastim
Paclitaxel
Home Care:G-CSF may be given at home by the patient or a family member if required.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
1 To determine if the combination of carboplatin and paclitaxel (TC) chemotherapy is therapeutically equivalent to the combination of doxorubicin, cisplatin and paclitaxel (TAP) chemotherapy with regards to survival
2 To determine if estrogen/progesterone receptor status provides prognostic information in patients treated with chemotherapy
3 To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile, specifically neurotoxicity and infection
4 To measure differences in patient reported neurotoxicity and Quality of Life among the regimens
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Study Status Information
Study Activation / Registration Date:01/26/2004
IRB Review and Approval Date:11/19/2003
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:1528
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must have primary Stage III or Stage IV or recurrent Endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor. Pathological confirmation and Estrogen receptor (ER)/Progesterone Receptor (PR) status of the primary tumor is mandatory. However, the results do not need to be available prior to registration.

2) Patients may not have received prior cytotoxic chemotherapy including chemotherapy used for radiation sensitization. Patients may have received prior radiation therapy, hormonal therapy or therapy with biologic agents, but such therapies must be discontinued prior to entry on this study.

3) Patients in whom both radiation and chemotherapy is planned must receive radiation prior to entry on this study.At least four weeks should have elapsed since completion of RT involving the whole pelvis or over 50% of the spine.

4) Patients must have adequate end-organ function as follows: Platelets >/= 100,000/mm3; Granulocytes (ANC) >/= 1,500/mm3; Creatinine </= ULN (CTC Grade 0) or calculated creatinine clearance (Jeliffe Formula) >/= 60ml/min; SGPT (ALT) </= 3 x upper limits of normal; Bilirubin </= institutional upper limits of normal.

5) Patients must have a GOG Performance Status of 0, 1, or 2.

6) Patients must have met the pre-entry requirements.

7) Patients must have signed an approved informed consent and authorization permitting release of personal health information.

8) Patients must be 18 years of age or older.

Exclusion Criteria:1) Patients with a concomitant malignancy other than non-melanoma skin cancer. With the exception of non-melanoma skin cancer, patients with a prior invasive malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy.

2) Patients in whom pathological confirmation and Estrogen Receptor (ER)/Progesterone Receptor (PR) status of the tumor is not obtainable.

3) Patients for whom radiation therapy is planned during or after study chemotherapy prior to demonstrated progression.

4) Patients with comcomitant medical illness such as serious uncontrolled infection, uncontrolled angina or serious peripheral neuropathy which, in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient.

5) Patients with third-degree or complete heart block are not eligible unless a pacemaker is in place. Patients on medications which alter cardiac conduction, such as digitalis, beta blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator.

6) Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligble unless a lef ventricular ejection fraction in the past 6 months is documented to be 50% or greater. Patients who have had a LVEF (performed for any reason) of less than 50% in the past 6 months are ineligible.

7) Patients whose circumstances will not permit study completion or adequate follow-up.

8) Patients who are sensitive to E.Coli-derived drug preparations.

9) Patients with uterine carcinosarcoma or other non-epithelial uterine malignancies.

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Links
Registration Number: NCT00063999
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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