Amreen Husain, MD
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: carboplatin
- Drug: cisplatin
- Drug: doxorubicin hydrochloride
- Drug: filgrastim
- Drug: paclitaxel
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma
o 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)
o 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
o 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
Key Exclusion Criteria:
Additional Study Details
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 CancerAnticipated start date:
5/3/2005Lead Sponsor:
Gynecologic Oncology GroupCollaborator(s):
- National Cancer Institute (NCI)
Investigator(s):
- Amreen Husain
- Chad Andrew Hamilton
- Nelson N Teng
- Oi Wah Stephanie Yap
- Jon Chan
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Duration of overall survival
Secondary Outcomes:
- Duration of progression-free survival
Total Number to be Enrolled:
1528Total Number to be Enrolled at Stanford:
8More Information
Secondary ID(s):
- 95949
- CDR0000305940
- GOG-0209
- GOG209
- NCT00063999
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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