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Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer


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

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Trial Information

Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer


OBJECTIVES:

- Determine the antitumor activity of capecitabine in patients with recurrent,
platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.

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

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 6-12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven recurrent ovarian epithelial or primary peritoneal cavity
cancer

- Measurable disease

- At least 1 unidimensionally measurable lesion

- Ascites and pleural effusions are not considered measurable disease

- Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease
containing carboplatin, cisplatin, or another organoplatinum compound

- Treatment-free interval of 6-12 months after response to platinum therapy

- Not eligible for higher priority GOG protocol

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 lower limit of normal

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 clearance at least 50 mL/min

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy (sensory and motor) greater than grade 1

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

- No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunologic therapy

- No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

- See Disease Characteristics

- If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed

- No prior capecitabine or fluorouracil

- No prior chemotherapy for recurrent or persistent disease, including pretreatment
with initial chemotherapy regimens

- Recovered from prior chemotherapy

Endocrine therapy:

- At least 1 week since prior hormonal therapy directed at malignant tumor

- Concurrent continuation of hormone replacement therapy allowed

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

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

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

Surgery:

- Recovered from prior surgery

Other:

- No prior cancer treatment that would preclude study therapy

- No concurrent amifostine or other protective reagents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068330

NCT ID:

NCT00006812

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Washington University School of MedicineSaint Louis, Missouri  63110
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
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Radiation Oncology BranchBethesda, Maryland  20892