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Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer


Phase 3
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer


OBJECTIVES:

- Compare the progression-free survival and response of patients with stage III or IV or
recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and
filgrastim (G-CSF) vs tamoxifen and megestrol.

- Compare the survival of patients treated with these regimens.

- Determine if progesterone receptor status provides information on whether patients are
more likely to benefit from chemotherapy.

- Compare the toxicity profiles of these treatment regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified
according to progesterone receptor status (negative vs positive). Patients are randomized to
1 of 2 treatment arms.

- Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes
followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and
filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days.
Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease
progression or unacceptable toxicity.

- At time of disease progression, patients cross-over to hormonal therapy as in arm II.

- Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on
weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity.

At time of disease progression, if patients have not previously been enrolled on arm I,
patients cross-over to receive chemotherapy as in arm I.

Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6
weeks on cross-over therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary stage III or IV or recurrent endometrial cancer

- Poor curative potential with radiotherapy or surgery (alone or in combination)

- Measurable disease

- At least one lesion accurately measured in at least one dimension

- At least 20 mm by conventional techniques, including palpation, x-ray, CT
scan, or MRI OR

- At least 10 mm by spiral CT scan

- Disease in a previously irradiated field as sole site of measurable disease
allowed only if clear progression after completion of radiotherapy

- Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required

- ER/PR status of measurable tumor optional

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3

Hepatic:

- Bilirubin normal

- SGPT no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 1.6 mg/dL

Cardiovascular:

- LVEF at least 50%

- No third-degree or complete heart block, unless pacemaker is in place

- Other conduction abnormalities or cardiac dysfunction allowed at the investigator's
discretion

- No history of deep venous thrombosis

- No uncontrolled angina

Pulmonary:

- No history of pulmonary embolus

Other:

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- No concurrent medical illness that would preclude study

- No serious uncontrolled infection

- No serious peripheral neuropathy

- No circumstances that would preclude study compliance

- No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior biologic therapy allowed

Chemotherapy:

- No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization

Endocrine therapy:

- No prior hormonal therapy for endometrial cancer

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50%
of the spine

Surgery:

- See Disease Characteristics

Other:

- Concurrent cardiac conduction-altering medications such as digitalis, beta blockers,
or calcium channel blockers allowed at the investigator's discretion

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jeffrey D. Bloss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068624

NCT ID:

NCT00016341

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Schneider Children's Hospital at North ShoreManhasset, New York  11030
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009