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Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer


OBJECTIVES:

- Determine the clinical activity of imatinib mesylate in patients with recurrent or
relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer or ovarian
low malignant potential tumor.

- Correlate the biochemical modulation of signal transduction pathways downstream of
platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinases in biopsy
tissue with outcome in patients treated with this drug.

- Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue
with response and outcome in patients treated with this drug.

- Investigate the potential antiangiogenic activity of this drug in microdissected tumor
cell and stromal lysates of these patients.

- Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy
tissue of patients treated with this drug.

- Evaluate the application of surface-enhanced laser desorption and ionization with
time-of-flight detection (SELDI-TOF) with artificial intelligence bioinformatics to
serially obtained serum samples for prediction of response in these patients and/or
toxicity of this drug.

OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cancer OR

- Histologically confirmed ovarian low malignant potential tumor with invasive
recurrence

- Relapsed after and/or refractory to platinum- and taxane-based chemotherapy

- Patients in first relapse after a disease-free interval of more than 1 year are
eligible

- Measurable disease outside prior radiation field

- Availability of a sentinel lesion that is adequate for core biopsy through
percutaneous biopsy or simple laparoscopic means

- Patients with clinical evidence of CNS involvement (abnormal clinical examination)
must have a negative CT scan with contrast or MRI of the brain

- No large volume ascites or pleural effusion

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion)

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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No myocardial infarction or unstable dysrhythmia within the past 6 months

- No congestive heart failure (CHF), including CHF that may be compensated with
furosemide

Other:

- No other invasive malignancy within the past 5 years except noninvasive nonmelanoma
skin cancer

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 months
after study completion

- Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the
discretion of the principal investigator (PI)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior signal transduction therapy

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin)

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Other:

- Recovered from prior anticancer therapy

- At least 1 week since prior antibiotics

- No more than 4 prior anticancer regimens

- No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin

- No concurrent therapeutic warfarin

- Patients who can be safely converted over to low molecular weight heparin are
eligible

- No concurrent grapefruit or grapefruit juice

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent alternative or complementary therapies or over-the-counter agents
unless approved by the PI

- Concurrent medications that may alter the metabolism of imatinib mesylate and lead to
potential toxicity are allowed at the discretion of the PI

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks

Safety Issue:

No

Principal Investigator

Elise C. Kohn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000069403

NCT ID:

NCT00039585

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • borderline ovarian surface epithelial-stromal tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892