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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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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 InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Stanford University Medical CenterStanford, California  94305-5408
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Washington University School of MedicineSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Community Hospital of Los GatosLos Gatos, California  95032
Lombardi Cancer CenterWashington, District of Columbia  20007
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Winship Cancer InstituteAtlanta, Georgia  30322
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Women's Cancer Center - Las VegasLas Vegas, Nevada  89102
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
University of Washington School of MedicineSeattle, Washington  98195
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Comprehensive Cancer CenterGlendale, California  91204
University of Kansas School of Medicine-WichitaWichita, Kansas  67214