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Endometrial CancerPhase 2NCT00003127

S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer

A Phase 2 study testing amifostine trihydrate, carboplatin and paclitaxel in people with Endometrial Cancer, run by SWOG Cancer Research Network at 94 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory… Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
amifostine trihydrate, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
94 sitesUnited States
Study dates
Feb 1998to Jul 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed metastatic, recurrent, or refractory epithelial endometrial carcinoma Must be one of the following histologic types: Endometrioid adenocarcinoma Villoglandular Secretory Ciliated Endometrioid adenocarcinoma with squamous differentiation Serous carcinoma Clear cell carcinoma Mucinous carcinoma Squamous carcinoma Mixed types of carcinoma Undifferentiated carcinoma Must not be amenable to surgery or radiotherapy Documented evidence of progression at site if the only site of measurable disease has been irradiated Metastatic sites need not be biopsied Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 25 mL/min Other: At least 5 years since other prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No more than 1 prior biologic therapy regimen Chemotherapy: No concurrent chemotherapy No prior taxane for any reason No more than 2 prior chemotherapy courses used for the sole purpose of radiosensitization during primary definitive therapy allowed No other prior chemotherapy Endocrine therapy: No concurrent hormonal therapy Prior hormonal or other endocrine therapy allowed Radiotherapy: No concurrent radiotherapy except to sites of bone metastases for palliative control of pain Prior radiotherapy to no more than 30% of bone marrow allowed At least 4 weeks since radiotherapy and recovered Surgery: Prior surgery allowed Must have recovered from surgery and any complication therefrom

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44195

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Texas Medical Branch

    Galveston, Texas, 77555-1329

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79423

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona, 85012

  • Oregon Cancer Center at Oregon Health Sciences University

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78284

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13210

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

Other trials in United States

About this study

Official title: Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory endometrial cancer.

Read the detailed description

OBJECTIVES: I. Evaluate the efficacy of paclitaxel and carboplatin with amifostine on progression free survival and overall survival in patients with metastatic or recurrent epithelial endometrial carcinoma not amenable to surgery or radiotherapy. II. Evaluate response (confirmed and unconfirmed partial response and complete response) rate to this regimen in this patient population. III. Assess the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours, then amifostine IV over 10 minutes, followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days. Treatment continues for 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 35 to 50 patients will be accrued for this study.

Being tested
amifostine trihydrate, carboplatin, paclitaxel
Keywords
stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amifostine trihydrateDrug

    Also called ethyol

    740 mg/m2 IV, Day 1, q 28 days X 6 cycles

  • carboplatinDrug

    Also called carbo

    target AUC=6, IV Day 1, q 28 days X 6 cycles

  • paclitaxelDrug

    Also called Taxol

    175 mg/m2, IV, Day 1 q 28 days X 6 cycles

Study groups in NCT00003127
Study groupRoleWhat they receive
carbo, taxol, amifostineExperimentalcarbo, taxol, amifostine
Receives: Drug: amifostine trihydrate; Drug: carboplatin; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.

    Measured: 6 months

Secondary outcomes (3)

  1. overall survival

    From date of registration to date of death due to any cause

    Measured: 6 months

  2. response

    Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No disease progression. No new lesions.

    Measured: after 12 and 24 weeks

  3. toxicity

    assessment per SWOG toxicity criteria

    Measured: Weekly X 3, q 4 weeks X 6 cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2004 (estimated)
  2. Study startFeb 1998
  3. Primary completionApr 2003
  4. Study completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003127
Sponsor's protocol ID
CDR0000065890
Other IDs
SWOG-S9720, U10CA032102
Status last verified
Jun 2012
First submitted
1 Nov 1999
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Scudder SA, Liu PY, Wilczynski SP, Smith HO, Jiang C, Hallum AV 3rd, Smith GB, Hannigan EV, Markman M, Alberts DS; Southwest Oncology Group. Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma: a phase II study of the Southwest Oncology Group. Gynecol Oncol. 2005 Mar;96(3):610-5. doi: 10.1016/j.ygyno.2004.11.024.

    PubMed 15721401

  • Scudder SA, Liu PY, Smith HO, et al.: Paclitaxel (PCT) and carboplatin (C) with amifostine (A) in advanced or recurrent endometrial cancer: a Southwest Oncology Group trial (S9720). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-819, 2001.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing amifostine trihydrate, carboplatin and paclitaxel in people with Endometrial Cancer, run by SWOG Cancer Research Network at 94 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003127, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.

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