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Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer


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

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Trial Information

Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer


OBJECTIVES:

- Determine the anti-tumor activity of gemcitabine and cisplatin in patients with
recurrent or refractory platinum-resistant ovarian epithelial cancer or primary
peritoneal carcinoma who have failed on higher priority treatment protocols.

- Determine the nature and degree of toxicity of this regimen in this patient population.

- Correlate ex vivo drug sensitivity and resistance with clinical response to this
regimen in these patients.

- Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo
measures of drug resistance in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1
and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease
progression.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary ovarian epithelial cancer or primary peritoneal
carcinoma

- Recurrent or persistent disease

- Bidimensionally measurable disease by physical examination or medical imaging
techniques

- Sonography is acceptable if lesions are clearly defined on initial examination
and bidimensionally measurable

- Ascites and pleural effusions are not considered measurable disease

- Must not be eligible for a higher priority Gynecologic Oncology Group protocol

- Must have received one, and only one, prior platinum-based chemotherapy regimen
containing carboplatin, cisplatin, or another organoplatinum compound for management
of primary disease

- Initial treatment may include high-dose therapy, consolidation, or extended
therapy administered after surgical or nonsurgical assessment

- If no prior paclitaxel, a second regimen containing paclitaxel allowed

- Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based
therapy of less than 6 months or progressed during platinum-based therapy)

PATIENT CHARACTERISTICS:

Age:

- Not specified

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 malignancy within the past 5 years except nonmelanoma skin cancer

- Sensory and motor neuropathy no greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunologic therapy for ovarian or
peritoneal cancer

Chemotherapy:

- See Disease Characteristics

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

- No prior gemcitabine

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

Endocrine therapy:

- At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer

- Concurrent continuation of hormonal replacement therapy allowed

Radiotherapy:

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

- No prior radiotherapy to only site of measurable disease

- No prior radiotherapy to more than 25% of bone marrow

Surgery:

- See Disease Characteristics

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

Other:

- At least 3 weeks since other prior therapy for ovarian or peritoneal cancer

- No prior cancer treatment that would preclude study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Cheryl A. Brewer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois College of Medicine at Peoria

Authority:

United States: Federal Government

Study ID:

CDR0000068041

NCT ID:

NCT00006028

Start Date:

January 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
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Tuft-New England Medical CenterBoston, Massachusetts  02111
CCOP - M.D. Anderson Research BaseHouston, Texas  77030-4009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Ellis Fischel Cancer CenterIndianapolis, Indiana  46285