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A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma


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

Thank you

Trial Information

A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma


OBJECTIVES:

- Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month
progression-free survival, in patients with persistent or recurrent ovarian epithelial
or primary peritoneal carcinoma.

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

- Determine the partial and complete response rates in patients treated with this drug.

- Determine the duration of progression-free and overall survival in patients treated
with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily. Courses repeat every 28 days 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 22-60 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

- Recurrent or persistent disease

- Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen
(e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease

- Platinum-resistant or refractory

- Treatment-free interval of less than 6 months after therapy with
platinum-containing regimen OR

- Progression during platinum-containing regimen OR

- Platinum sensitive defined as treatment-free interval without disease
progression for more than 6 months but less than 12 months after therapy with
platinum-containing regimen

- At least 1 lesion measurable in at least 1 dimension

- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, or MRI) OR

- At least 10 mm by spiral CT scan

- At least 1 target lesion outside a previously irradiated field

- Disease must be accessible to core needle biopsy

- Ineligible for higher priority GOG protocol

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

Cardiovascular:

- No unstable cardiac disease

- No myocardial infarction within the past 6 months

- Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on
stable regimen for at least 3 months

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No sensory or motor neuropathy greater than grade 1

- No active corneal disease (e.g., keratoconjunctivitis)

- No active infection requiring antibiotics

- No evidence of bowel dysfunction that could be related to early bowel obstruction

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior immunological agents for the malignancy

- No concurrent anti-cancer immunotherapy

Chemotherapy:

- See Disease Characteristics

- No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or
persistent disease

- No prior noncytotoxic chemotherapy for recurrent or persistent disease

- At least 3 weeks since prior chemotherapy for the malignancy and recovered

- No concurrent anti-cancer chemotherapy

Endocrine therapy:

- At least 1 week since prior anticancer hormonal therapy

- Concurrent hormone replacement therapy allowed

- No concurrent anti-cancer hormonal therapy

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for the malignancy and recovered

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

- No concurrent anti-cancer radiotherapy

Surgery:

- At least 4 weeks since prior surgery (except minor procedures under local anesthesia
(e.g., central venous port placement)) and recovered

Other:

- At least 3 weeks since other prior therapy for the malignancy

- No prior gefitinib

- No other prior epidermal growth factor receptor inhibitors

- No prior anticancer therapy that would preclude study therapy

- No concurrent chlorpromazine

- No other concurrent investigational agents

- No other concurrent antineoplastic agents

- No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine,
barbiturates, nafcillin, rifampicin, or St. John's Wort

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068852

NCT ID:

NCT00023699

Start Date:

August 2001

Completion Date:

May 2006

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
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
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
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
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
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
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
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
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
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
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
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Schneider Children's Hospital at North ShoreManhasset, New York  11030
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Medical Oncology Clinical Research UnitBethesda, Maryland  20892