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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
Not Enrolling
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


- 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

Inclusion Criteria


- 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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


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

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


- 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


- Creatinine no greater than 1.5 times ULN


- 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


- 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


Biologic therapy:

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

- No concurrent anti-cancer immunotherapy


- 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


- 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


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


- 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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




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



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