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A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer


OBJECTIVES:

- Determine the antitumor activity of paclitaxel in patients with recurrent or persistent
platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.

- Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment
repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or persistent ovarian epithelial or primary
peritoneal cancer

- Measurable disease

- At least 1 lesion measured in at least 1 dimension

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- At least 1 target lesion

- Tumors within a previously irradiated field considered non-target lesions

- Paclitaxel resistant

- Treatment-free interval of less than 6 months duration after treatment with
prior paclitaxel OR

- Progression during prior paclitaxel-based therapy

- Platinum resistant or refractory

- Treatment-free interval of less than 6 months duration after treatment with
prior platinum OR

- Progression during prior platinum-based therapy

- Ineligible for higher priority GOG protocol (any active GOG phase III protocol for
the same patient population)

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

- No other prior invasive malignancy within the past 5 years except nonmelanoma skin
cancer

- No grade 2 or greater neuropathy (sensory and motor)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunologic agents for cancer

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy for cancer and recovered

- Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens
containing carboplatin, cisplatin, or other organoplatinum compound for primary or
recurrent disease

- Initial treatment may include high-dose therapy, consolidation, or extended therapy

- Received at least 1 prior paclitaxel-based chemotherapy regimen

- No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval
between doses

- No additional prior cytotoxic chemotherapy for recurrent or persistent disease,
including retreatment with initial chemotherapy regimens

Endocrine therapy:

- At least 1 week since prior hormonal therapy for cancer

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for cancer and recovered

- No prior radiotherapy to site(s) of measurable disease

- No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

- At least 3 weeks since prior surgery for cancer and recovered

Other:

- At least 3 weeks since other prior therapy for cancer

- No prior anticancer treatment that would preclude study

- No concurrent amifostine or other protective reagents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Maurie Markman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068875

NCT ID:

NCT00023907

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Memorial Medical CenterSpringfield, Illinois  62781
Women's Cancer Center at Community Hospital of Los GatosLos Gatos, California  95032
Genecologic Oncology NetworkNashville, Tennessee  37203