Clinical trial · Interventional
Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma
NCT00003691CI-TRIAL-00011230completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma * Very poor potential for cure by radiotherapy or surgery alone or in combination * Measurable disease * Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over 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 * SGPT no greater than 3 times upper limit of normal * Bilirubin normal Renal * Creatinine no greater than 1.6 mg/dL Cardiovascular * LVEF at least 50% within past 6 months * No uncontrolled angina * No third-degree or complete heart block unless a pacemaker is in place Neurologic * No serious peripheral neuropathy Other * No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer * No uncontrolled infection * No sensitivity to E. coli-derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed * No concurrent biologic therapy Chemotherapy * No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization * No prior chemotherapy for any prior malignancy Endocrine therapy * Prior hormone therapy allowed * No concurrent hormone therapy Radiotherapy * At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine Surgery * Not specified
References
Publications (10)
- BACKGROUNDFarley JH, Tian C, Rose GS, Brown CL, Birrer M, Risinger JI, Thigpen JT, Fleming GF, Gallion HH, Maxwell GL. Chemotherapy intensity and toxicity among black and white women with advanced and recurrent endometrial cancer: a Gynecologic Oncology Group Study. Cancer. 2010 Jan 15;116(2):355-61. doi: 10.1002/cncr.24769. PMID 19924790
- BACKGROUNDMoore KN, Tian C, McMeekin DS, Thigpen JT, Randall ME, Gallion HH. Does the progression-free interval after primary chemotherapy predict survival after salvage chemotherapy in advanced and recurrent endometrial cancer?: a Gynecologic Oncology Group ancillary data analysis. Cancer. 2010 Dec 1;116(23):5407-14. doi: 10.1002/cncr.25480. Epub 2010 Aug 24. PMID 20737572
- BACKGROUNDMcMeekin DS, Filiaci VL, Thigpen JT, Gallion HH, Fleming GF, Rodgers WH; Gynecologic Oncology Group study. The relationship between histology and outcome in advanced and recurrent endometrial cancer patients participating in first-line chemotherapy trials: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Jul;106(1):16-22. doi: 10.1016/j.ygyno.2007.04.032. PMID 17574073
- BACKGROUNDModesitt SC, Tian C, Kryscio R, Thigpen JT, Randall ME, Gallion HH, Fleming GF; Gynecologic Oncology Group. Impact of body mass index on treatment outcomes in endometrial cancer patients receiving doxorubicin and cisplatin: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Apr;105(1):59-65. doi: 10.1016/j.ygyno.2006.10.045. Epub 2006 Dec 5. PMID 17150247
- BACKGROUNDMaxwell GL, Tian C, Risinger J, Brown CL, Rose GS, Thigpen JT, Fleming GF, Gallion HH, Brewster WR; Gynecologic Oncology Group study. Racial disparity in survival among patients with advanced/recurrent endometrial adenocarcinoma: a Gynecologic Oncology Group study. Cancer. 2006 Nov 1;107(9):2197-205. doi: 10.1002/cncr.22232. PMID 17001661
- BACKGROUNDModesitt S, Tian C, Kryscio R, et al.: Impact of body mass index (BMI) on treatment outcomes in advanced or recurrent endometrial cancer patients receiving doxorubicin/cisplatin chemotherapy: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-93, 2006.