AzTrials
AzTrials

Fallopian Tube CancerPhase 2NCT00003896

S9912 Combination Chemo in Stage III Ovarian Cancer,

A Phase 2 study testing cisplatin, liposomal doxorubicin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by SWOG Cancer Research Network at 104 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 work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Read more about this study

Who is it for?
Any age, women only
What is being tested?
cisplatin, liposomal doxorubicin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
104 sitesUnited States
Study dates
Sep 1999to Feb 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
  • Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
  • No tumors of borderline or low malignant potential only
  • Mixed Mullerian tumors allowed
  • Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
  • Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • SWOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2 times ULN

Renal:

  • Creatinine clearance ≥ 50 mL/min

Cardiovascular:

  • No congestive heart failure
  • No cardiac arrhythmia
  • No myocardial infarction or unstable angina within the past 6 months
  • Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active or uncontrolled infection
  • No concurrent fever
  • No grade 2 or greater sensory neuropathy
  • No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
  • No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
  • No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for ovarian cancer

Chemotherapy:

  • No prior chemotherapy for ovarian cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior pelvic radiotherapy for ovarian cancer

Surgery:

  • See Disease Characteristics
  • Recovered from all reversible surgery-related toxic effects

Other:

  • No other concurrent antitumor treatment
  • No concurrent antibiotics for infection of undetermined etiology

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

United States104 sites

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Cancer Care Center at Battle Creek Health System

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Providence Hospital

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • University of California Davis Cancer Center

    Davis, California, 95616

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Breslin Cancer Center at Ingham Regional Medical Center

    East Lansing, Michigan, 48824-1313

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Spectrum Health Hospital - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Good Samaritan Health Systems

    Kearney, Nebraska, 68847

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Valley Memorial Hospital

    Livermore, California, 94550

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Judy L. Schmidt, MD, FACP, P. C.

    Missoula, Montana, 59804

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Cancer Care Center at Skagit Valley Hospital

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Highland General Hospital

    Oakland, California, 94602

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 95806

  • Capital Medical Center

    Olympia, Washington, 98507

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26101

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Mercy Hospital

    Port Huron, Michigan, 48060

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Salem Hospital Regional Cancer Center

    Salem, Oregon, 97309

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • J.C. Robinson, M.D. Regional Cancer Center

    San Pablo, California, 94806

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

RATIONALE: Drugs used in chemotherapy work in 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 combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Determine the feasibility of and toxic effects associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Being tested
cisplatin, liposomal doxorubicin, paclitaxel
Keywords
stage III ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • cisplatinDrug

    Also called platinol

  • liposomal doxorubicinDrug

    Also called pegylated liposomal doxorubicin hydrochloride, doxil

  • paclitaxelDrug

    Also called taxol

Study groups in NCT00003896
Study groupRoleWhat they receive
Paclitaxel/cisplatin/Liposomal DoxorubicinExperimentalpaclitaxel, cisplatin and liposomal doxorubicin
Receives: Drug: cisplatin; Drug: liposomal doxorubicin; 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 progression (as defined per RECIST), symptomatic deterioration or death due to any cause.

    Measured: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.

  2. Overall Survival

    from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact

    Measured: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.

Secondary outcomes (1)

  1. Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Weekly during 6 weeks of protocol treatment

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 1999
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003896
Sponsor's protocol ID
CDR0000067066
Other IDs
S9912, U10CA032102
Status last verified
Jan 2013
First submitted
1 Nov 1999
Last updated
4 Jan 2013
Data monitoring committee
No

Publications

  • Smith HO, Moon J, Wilczynski SP, Tiersten AD, Hannigan EV, Robinson WR, Rivkin SE, Anderson GL, Liu PY, Markman M. Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecol Oncol. 2009 Aug;114(2):206-9. doi: 10.1016/j.ygyno.2009.04.023. Epub 2009 May 23.

    PubMed 19464730

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, liposomal doxorubicin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by SWOG Cancer Research Network at 104 sites in United States.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 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?

Yes. Results are posted in the registry (first posted 29 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.). The study lists 2 primary outcomes in all. 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 NCT00003896, which also lists 1 linked publication.

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 4 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in