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
This study is being done on women who have cancer of the endometrium (lining of the womb), that cannot be cured with surgery or radiation therapy. In a previous study, women with an advanced stage of endometrium cancer showed improved chances of survival after receiving chemotherapy. In advanced or recurrent endometrial cancer, the Gynecologic Oncology Group (GOG) has used chemotherapy with the drugs cisplatin, doxorubicin and paclitaxel to treat these patients. Additionally, other doctors have used the drugs carboplatin and paclitaxel to treat similar patients. Both of these treatments have been shown to shrink tumors in patients with endometrial cancer.
The purpose of this study is to find out whether treatment with the two-drug combination of carboplatin and paclitaxel is as good as the current standard three-drug combination of cisplatin, doxorubicin, and paclitaxel. Side effect information will also be analyzed to see if there are any differences between the two-drug and three-drug chemotherapy combinations with regard to ease of treatment and patient tolerance. Lastly, there are no known treatments for endometrial cancer that have been shown to be better than these two chemotherapy regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: paclitaxel Drug: doxorubicin Drug: cisplatin Drug: filgrastim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label 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 [ Time Frame: Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ] [ Designated as safety issue: No ]
- Duration of progression-free survival [ Time Frame: Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ] [ 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: 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.
|
Drug: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Drug: doxorubicin
Patients receive doxorubicin IV over 15 minutes on day 1
Other Name: doxorubicin hydrochloride
Drug: cisplatin
cisplatin IV over 60-90 minutes on day 1
Drug: filgrastim
filgrastim (G-CSF) subcutaneously on days 3-12
Other Name: (G-CSF)
|
|
Active Comparator: 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: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
|
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| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07101 | |
| Study Chair: | David S. Miller, MD | Simmons Cancer Center |
More Information
No publications provided
| Responsible Party: | DAVID SCOTT MILLER, M.D. Study Chair, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00698620 History of Changes |
| Other Study ID Numbers: | 0120040379 |
| Study First Received: | June 12, 2008 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Institutional Review Board |
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 Lenograstim 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 |
ClinicalTrials.gov processed this record on May 16, 2013