- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00027690
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
A Phase II Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.
IV. Determine the effects of this drug on the levels of epidermal growth factor receptors (EGFR), c-ErbB2 (HER-2/neu) receptors, estrogen receptors (ER), and progesterone receptors (PR) (both PR and PRB) in tumor specimens of these patients.
V. Determine if an association exists between the levels of EGFR, ER, PR, PRB, and HER-2/neu serum concentrations of gefitinib, gefitinib activity, and soluble EGFR and clinical outcome in patients treated with this drug.
VI. Determine the frequency of clinical response (partial and complete response) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-28. 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: A total of 22-60 patients will be accrued for this study within 2.5-6 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19103
- Gynecologic Oncology Group
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Histologically confirmed primary endometrial carcinoma
- Recurrent or persistent disease
Received 1 prior chemotherapy regimen for endometrial carcinoma
- Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI)
- At least 10 mm by spiral CT scan
- Must have at least 1 target lesion for response assessment
Tumors within a previously irradiated field are designated as non-target lesions
- Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
- Must have a tumor that is accessible for guided core needle or fine needle biopsy
- Ineligible for a higher priority GOG protocol, defined as any active phase III protocol for the same patient population, if one exists
- Performance status - GOG 0-2 (for patients who received 1 prior regimen)
- Performance status - GOG 0-1 (for patients who received 2 prior regimens)
- 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 or myocardial infarction within the past 6 months
- History of coronary artery disease, congestive heart failure, or dysrhythmia allowed if on a stable regimen for at least 3 months
- No active infection requiring antibiotics
- No active corneal disease (e.g., keratoconjunctivitis)
- No grade 2 or greater sensory and motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No signs or symptoms of bowel dysfunction that would preclude successful ingestion of oral study medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 3 weeks since prior immunologic agents directed at malignant tumor
- No concurrent anticancer immunotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy directed at the malignant tumor and recovered
- No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- No concurrent anticancer chemotherapy
- At least 1 week since prior hormonal therapy directed at malignant tumor
- No concurrent anticancer hormonal therapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
- No concurrent anticancer radiotherapy
- At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered
- At least 3 weeks since any other prior therapy directed at malignant tumor
- One additional prior cytotoxic regimen for recurrent or persistent disease allowed
- No prior gefitinib or other epidermal growth factor receptor inhibitor
- No prior cancer treatment that would contraindicate study therapy
- No concurrent CYP 3A4 inducers (including phenytoin, carbamazepine, barbiturates, nafcillin, rifampin, or Hypericum perforatum [St. John's Wort])
- No other concurrent investigational or antineoplastic agents
- No concurrent chlorpromazine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Korrelative studier
Given orally
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Andel pasienter i live og progresjonsfri
Tidsramme: 6 måneder
|
6 måneder
|
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0
Tidsramme: Up to 5 years
|
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Duration of overall survival
Tidsramme: Up to 5 years
|
Up to 5 years
|
Duration of progression-free survival
Tidsramme: Up to 5 years
|
Up to 5 years
|
Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Tidsramme: Up to 5 years
|
Up to 5 years
|
Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)
Tidsramme: Baseline to end of course 5
|
Baseline to end of course 5
|
Initial performance status and histological grade
Tidsramme: Baseline to end of course 5
|
Baseline to end of course 5
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kimberly Leslie, Gynecologic Oncology Group
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCI-2012-02429 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH-stipend/kontrakt)
- CDR0000069057
- GOG-0229C (Annen identifikator: CTEP)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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