Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049556
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2002-11-12
Brief Title:
Gefitinib in Treating Patients With Cervical Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor ZD1839 Iressa Gefitinib in Patients With Epithelial Ovarian Cancer or Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of cervical cancer Comparing results of diagnostic procedures performed before during and after treatment with gefitinib may help doctors predict a patients response to treatment and help plan the most effective treatment
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with cervical cancer
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with cervical cancer
Detailed Description:
OBJECTIVES
Determine the reduction in phosphorylation of epidermal growth factor receptor EGFR AKT and ERK by proteomics in tumor and normal skin of patients with ovarian epithelial cancer or cervical cancer receiving gefitinib Open to accrual for cervical cancer patients only as of 452005
Determine the clinical activity of this drug in these patients
Determine the toxicity of this drug in these patients
Correlate the biologic modulation of EGFR ERK and AKT by this drug with outcome and toxic effects in these patients
Correlate EGFR modulation in skin with outcome and toxic effects in patients treated with this drug
Correlate expression of EGFR and phosphorylated-EGFR in tissue biopsies from these patients with biochemical modulation and outcome
Determine the application of surface-enhanced laser desorption and ionization with time-of-flight detection SELDI-TOF and artificial intelligence bioinformatics to serially obtained serum samples for predicting response and toxic effects in these patients
OUTLINE Patients are stratified according to disease cervical cancer vs ovarian epithelial fallopian tube and primary peritoneal cancer Open to accrual for cervical cancer patients only as of 452005
Patients receive oral gefitinib daily Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Biopsies of a sentinel lesion with CT guidance or laparoscopy are obtained at baseline and at 4 weeks Skin biopsies of unaffected areas are also obtained at these time points Tissue is examined using immunohistochemical methods Proteomic profiling using surface-enhanced laser desorptionionization with time-of-flight SELDI-TOF mass spectrometry is conducted on serum at baseline and then every 4 weeks
Patients are followed monthly
PROJECTED ACCRUAL A total of 30-40 patients 15-20 per stratum will be accrued for this study within 10-12 months Open to accrual for cervical cancer patients only as of 452005
Determine the reduction in phosphorylation of epidermal growth factor receptor EGFR AKT and ERK by proteomics in tumor and normal skin of patients with ovarian epithelial cancer or cervical cancer receiving gefitinib Open to accrual for cervical cancer patients only as of 452005
Determine the clinical activity of this drug in these patients
Determine the toxicity of this drug in these patients
Correlate the biologic modulation of EGFR ERK and AKT by this drug with outcome and toxic effects in these patients
Correlate EGFR modulation in skin with outcome and toxic effects in patients treated with this drug
Correlate expression of EGFR and phosphorylated-EGFR in tissue biopsies from these patients with biochemical modulation and outcome
Determine the application of surface-enhanced laser desorption and ionization with time-of-flight detection SELDI-TOF and artificial intelligence bioinformatics to serially obtained serum samples for predicting response and toxic effects in these patients
OUTLINE Patients are stratified according to disease cervical cancer vs ovarian epithelial fallopian tube and primary peritoneal cancer Open to accrual for cervical cancer patients only as of 452005
Patients receive oral gefitinib daily Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Biopsies of a sentinel lesion with CT guidance or laparoscopy are obtained at baseline and at 4 weeks Skin biopsies of unaffected areas are also obtained at these time points Tissue is examined using immunohistochemical methods Proteomic profiling using surface-enhanced laser desorptionionization with time-of-flight SELDI-TOF mass spectrometry is conducted on serum at baseline and then every 4 weeks
Patients are followed monthly
PROJECTED ACCRUAL A total of 30-40 patients 15-20 per stratum will be accrued for this study within 10-12 months Open to accrual for cervical cancer patients only as of 452005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0303 | None | None | None |
| NCI-5561 | None | None | None |