Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: gefitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma |
| Study Start Date: | August 2001 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 53 Study Locations| Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00023699 History of Changes |
| Other Study ID Numbers: | CDR0000068852, GOG-0170C |
| Study First Received: | September 13, 2001 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013