Clinical trial · Interventional
Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer
- 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 work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival as measured by Kaplan Meier and RECIST at 18 months
Secondary outcomes (2)
- measure
- Overall survival as measured by Kaplan Meier after each course, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
- measure
- Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria: * Advanced metastatic and/or relapsed disease * Locally advanced inoperable or unresectable disease * No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements * Uterine papillary serous carcinoma allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 g/dL (transfusions allowed) Hepatic * ALT and AST less than 2 times upper limit of normal (ULN) * Alkaline phosphatase less than 2 times ULN * Bilirubin less than 1.5 times ULN Renal * Creatinine less than 1.5 times ULN * Creatinine clearance greater than 50 mL/min Cardiovascular * Normal baseline EKG * Normal baseline LVEF on MUGA or echocardiogram for patients who received prior anthracyclines Other * Able to tolerate high-dose dexamethasone * Must be considered fit for chemotherapy * No uncontrolled infection * No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix * No prior nervous or psychiatric disorder that would preclude study compliance * No psychological, familial, sociological, or geographic condition that would preclude study participation * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 12 months since prior adjuvant chemotherapy * Total dose of prior doxorubicin no greater than 200 mg/m\^2 * Total dose of prior epirubicin no greater than 300 mg/m\^2 Endocrine therapy * At least 28 days since prior hormonal therapy for patients with partial or complete response after first-line treatment Radiotherapy * No prior radiotherapy to any area other than pelvis * No concurrent radiotherapy Surgery * Not specified Other * No other concurrent anticancer medications
References
Publications (0)
Data not yet available