Brief Title
S9912 Combination Chemo in Stage III Ovarian Cancer,
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
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival
Secondary Outcome
Adverse Events
Condition
Fallopian Tube Cancer
Intervention
cisplatin
Study Arms / Comparison Groups
Paclitaxel/cisplatin/Liposomal Doxorubicin
Description: paclitaxel, cisplatin and liposomal doxorubicin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
September 1999
Completion Date
February 2008
Primary Completion Date
February 2008
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Harriet O. Smith, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003896
Organization ID
CDR0000067066
Secondary IDs
S9912
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Harriet O. Smith, MD, Study Chair, University of New Mexico Cancer Center
Verification Date
January 2013