Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00052312
First received: January 24, 2003
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
Primary Outcome Measures:
- Progression-free survival as measured by Kaplan Meier and RECIST at 18 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Designated as safety issue: No ]
- Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course [ Designated as safety issue: Yes ]
| Enrollment: | 141 |
| Study Start Date: | September 2002 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the progression-free survival at 18 months of patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052312
Show 35 Study Locations
Show 35 Study LocationsSponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Nicholas S. Reed, MD | University of Glasgow |
| Study Chair: | Giorgio Bolis, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00052312 History of Changes |
| Other Study ID Numbers: | EORTC-55984, EORTC-55984 |
| Study First Received: | January 24, 2003 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma endometrial papillary serous carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Neoplasms, Glandular and Epithelial Cisplatin Doxorubicin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013