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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00023699




Registration number
NCT00023699
Ethics application status
Date submitted
13/09/2001
Date registered
15/10/2003
Date last updated
24/06/2013

Titles & IDs
Public title
Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Scientific title
A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Secondary ID [1] 0 0
GOG-0170C
Secondary ID [2] 0 0
CDR0000068852
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Primary Peritoneal Cavity Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - gefitinib

Treatment: Drugs: gefitinib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australia New Zealand Gynaecological Oncology Trials Group - Camperdown
Recruitment postcode(s) [1] 0 0
1450 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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Florida
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Illinois
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Indiana
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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United States of America
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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United States of America
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Washington
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Canada
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Alberta
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United Kingdom
State/province [29] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Gynecologic Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor
cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have
recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00023699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Russell J. Schilder, MD
Address 0 0
Fox Chase Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00023699