Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Paclitaxel Carboplatin Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Duration of overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063999

Show 505 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	David S. Miller, MD	Simmons Cancer Center

More Information


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 Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Paclitaxel Liposomal doxorubicin Albumin-Bound Paclitaxel Cisplatin Carboplatin Doxorubicin	Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016