NCT00003896|CompletedPhase 2Results

S9912 Combination Chemo in Stage III Ovarian Cancer,

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

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000067066S9912U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

104

Timeline

RegisteredJan 2003

StartedSep 1999

CompletionFeb 2008

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 1999

Longer than P75 for phase_2

Geographic Reach

1 country

104 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.4 years study duration

Study Start

First participant enrolled

September 1, 1999

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

4.8 years until next milestone

Results Posted

Study results publicly available

November 29, 2012

Completed

Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

8.4 years

First QC Date

November 1, 1999

Results QC Date

October 30, 2012

Last Update Submit

January 2, 2013

Conditions

Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancerperitoneal cavity cancerfallopian tube cancer

Outcome Measures

Primary Outcomes (2)

Progression-free Survival
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
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
Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.

Secondary Outcomes (1)

Adverse Events
Weekly during 6 weeks of protocol treatment

Study Arms (1)

Paclitaxel/cisplatin/Liposomal Doxorubicin

EXPERIMENTAL

paclitaxel, cisplatin and liposomal doxorubicin

Drug: cisplatinDrug: liposomal doxorubicinDrug: paclitaxel

Interventions

cisplatinDRUG

Also known as: platinol

Paclitaxel/cisplatin/Liposomal Doxorubicin

liposomal doxorubicinDRUG

Also known as: pegylated liposomal doxorubicin hydrochloride, doxil

Paclitaxel/cisplatin/Liposomal Doxorubicin

paclitaxelDRUG

Also known as: taxol

Paclitaxel/cisplatin/Liposomal Doxorubicin

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (104)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

University of California Davis Cancer Center

Davis, California, 95616, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Valley Memorial Hospital

Livermore, California, 94550, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

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

San Pablo, California, 94806, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

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

Alton, Illinois, 62002, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

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

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Cancer Care Center at Battle Creek Health System

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

East Lansing, Michigan, 48824-1313, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Spectrum Health Hospital - Blodgett Campus

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

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

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium