A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
18 Years
N/A
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in
patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer
treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile
of this regimen in this patient population. III. Determine the incidence of infectious and
hematologic complications in patients treated with this regimen. IV. Determine the
progression-free survival of patients with no disease or minimal disease burden after
initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis
markers and immunologic parameters with response in patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to participating center. Patients are randomized to one of three IM-862 doses.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy
initiation and continues until clinical evidence of disease progression or until 3 days
before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses
intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as
in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily.
Patients undergo second-look surgery within 4-8 weeks after completion of the last course of
chemotherapy. Patients with a complete pathologic response or only microscopically
detectable residual disease receive consolidation therapy with IM-862, according to their
original treatment arm. Consolidation therapy begins within 3-14 days after second-look
surgery and continues for 24 weeks in the absence of disease progression. Patients are
followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study
within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial cancer or
primary peritoneal carcinoma of one of the following cell types: Serous adenocarcinoma
Mucinous adenocarcinoma Clear-cell adenocarcinoma Endometrioid Adenocarcinoma (not
otherwise specified) Undifferentiated carcinoma Transitional cell Malignant Brenner's
tumor Mixed epithelial carcinoma No borderline tumor (tumor of low malignant potential)
Underwent prior standard initial cytoreductive surgery within the past 6 weeks Optimally
resected disease with no residual site of disease more than 1 cm in greatest dimension
Removal of all disease extending beyond the reproductive tract Total hysterectomy and
bilateral salpingo-oopherectomy at cytoreductive surgery or in the past
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no
greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other
malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of
the cervix or breast No other major systemic medical illness that would preclude survival
No poor general condition or medical, social, or psychosocial factors that would preclude
study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for current
malignancy At least 5 years since prior gene therapy At least 1 year since prior
interleukin-2 (IL-2) At least 1 year since prior sargramostim (GM-CSF) Concurrent
filgrastim (G-CSF) allowed No concurrent gene therapy No concurrent GM-CSF No concurrent
IL-2 No other concurrent angiogenesis inhibitors (e.g., thalidomide, cyclooxygenase-2
inhibitors (e.g., rofecoxib or celecoxib), interferon products, or angiotensin-converting
enzyme inhibitors) Chemotherapy: At least 5 years since prior anticancer chemotherapy No
prior chemotherapy for current malignancy No other concurrent chemotherapy Endocrine
therapy: No prior endocrine therapy for current malignancy At least 1 year since prior
tamoxifen No concurrent tamoxifen Radiotherapy: No prior radiotherapy for current
malignancy Surgery: See Disease Characteristics Other: At least 1 year since prior
experimental or investigational medications No other concurrent experimental or
investigational medications
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Pamela Paley, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Pacific Gynecology Specialists
Authority:
United States: Federal Government
Study ID:
CDR0000068674
NCT ID:
NCT00017303
Start Date:
January 2001
Completion Date:
Related Keywords:
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage III ovarian epithelial cancer
- ovarian undifferentiated adenocarcinoma
- ovarian mixed epithelial carcinoma
- ovarian serous cystadenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- primary peritoneal cavity cancer
- Brenner tumor
- Ovarian Neoplasms
- Peritoneal Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Community Hospital of Los Gatos | Los Gatos, California 95032 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Winship Cancer Institute | Atlanta, Georgia 30322 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Women's Cancer Center - Las Vegas | Las Vegas, Nevada 89102 |
| Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
| Comprehensive Cancer Center | Glendale, California 91204 |
| University of Kansas School of Medicine-Wichita | Wichita, Kansas 67214 |
