Brief Title
S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Official Title
Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Brief 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 or combining chemotherapy with surgery
may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in
treating patients who have stage III or stage IV ovarian epithelial cancer, primary
peritoneal cancer, or fallopian tube cancer.
Detailed Description
OBJECTIVES:
- Evaluate the overall survival and progression-free survival in patients with stage III
or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant
paclitaxel and carboplatin.
- Estimate the percentage of these patients whose disease is successfully cytoreduced to
less than 1 cm in diameter following neoadjuvant chemotherapy.
- Evaluate the toxicity of this regimen in these patients.
- Explore the relationship between tumor p53 expression, proliferation rate as measured by
proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay
results at time of debulking surgery with progression-free survival and overall survival
in these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in
the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the
third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo
debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to
below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by
carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats
every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually for up to 5 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Survival
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Study Arms / Comparison Groups
chemo/debulking surgery/IP chemo
Description: neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
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
62
Start Date
March 2001
Completion Date
November 2009
Primary Completion Date
September 2009
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer,
primary peritoneal cancer, or fallopian tube cancer
- Adenocarcinoma
- Large pelvic mass and/or bulky abdominal disease and/or malignant pleural
effusion
- Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant
metastases not allowed)
- No borderline or low-malignant potential tumors
- Optimal cytoreduction clinically deemed unlikely
- CA 125 at least 70 units/mL
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT no greater than 2 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No congestive heart failure or cardiac arrhythmia
- No myocardial infarction or angina within past 6 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or
gastrointestinal bleeding
- No grade 2 or greater sensory neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately
treated stage I or II cancer in complete remission
- No active or uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for this cancer
Chemotherapy:
- No prior chemotherapy for this cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior pelvic radiation for this cancer
Surgery:
- See Disease Characteristics
- Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure
was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy
with omentectomy)
- Prior salpingo-oophorectomy and/or partial omentectomy allowed
Other:
- No other concurrent anti-cancer therapy
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Amy D. Tiersten, MD, ,
Administrative Informations
NCT ID
NCT00008138
Organization ID
CDR0000068380
Secondary IDs
U10CA032102
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Amy D. Tiersten, MD, Study Chair, NYU Langone Health
Verification Date
December 2015