Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

cisplatin

+ liposomal doxorubicin

+ paclitaxel

Drug
Who is being recruted

Urogenital Diseases+18

+ Genital Diseases

+ Adnexal Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003896
Principal SponsorSWOG Cancer Research Network
Last updated: January 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialFallopian Tube NeoplasmsOvarian Neoplasms

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
paclitaxel, cisplatin and liposomal doxorubicin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 104 locations

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, United StatesOpen Arizona Cancer Center at University of Arizona Health Sciences Center in Google Maps

University of California Davis Cancer Center

Davis, United States

City of Hope Comprehensive Cancer Center

Duarte, United States

Saint Rose Hospital

Hayward, United States
Completed104 Study Centers