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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
Outcome Time Frame:
assessed ever 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
Safety Issue:
No
Principal Investigator
Amy D. Tiersten, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000068380
NCT ID:
NCT00008138
Start Date:
March 2001
Completion Date:
November 2009
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- ovarian undifferentiated adenocarcinoma
- ovarian serous cystadenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- fallopian tube cancer
- peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
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