Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer |
- Duration of overall survival [ Designated as safety issue: No ]
- Duration of progression-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 900 |
| Study Start Date: | August 2003 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
|
Biological: filgrastim
Given by injection
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
Detailed Description:
OBJECTIVES:
- Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
- Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
- Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.
- Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
- FIGO stage III or IV or recurrent disease
- Must know estrogen and progesterone status of the primary tumor
- Poor potential for curative treatment by radiotherapy and/or surgery
At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
- Disease in a previously irradiated field acceptable as the only site of measurable disease only if 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
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin normal
- ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 1.6 mg/dL
Cardiovascular
- LVEF at least 50%
- Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
- No third-degree or complete heart block without a pacemaker
- No uncontrolled angina
- No myocardial infarction within the past 6 months
- No New York Heart Association class II -IV heart failure
- No symptoms of congestive heart failure
Other
- Not pregnant or nursing
- Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
- No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
- No serious uncontrolled infection
- No serious peripheral neuropathy
- No other concurrent medical illness that would preclude study therapy
- No circumstances that would preclude study completion or follow-up
- No sensitivity to Escherichia coli-derived drug preparations
- No uterine carcinosarcoma or other non-epithelial uterine malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy allowed
- No concurrent biologic therapy
Chemotherapy
- No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy
Endocrine therapy
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
- No concurrent radiotherapy
Surgery
- Not specified
Other
- Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
Contacts and Locations
Show 505 Study Locations| Study Chair: | David S. Miller, MD | Simmons Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00063999 History of Changes |
| Other Study ID Numbers: | CDR0000305940, GOG-0209 |
| Study First Received: | July 8, 2003 |
| Last Updated: | April 23, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial 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 Carboplatin Paclitaxel Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 19, 2013