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A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer

Phase 2
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer


I. Determine the response rates (confirmed, complete, and partial) in patients with
platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal
cancer treated with imatinib mesylate.

II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily,
CD117 and platelet-derived growth factor receptor expression levels with response in
patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria:

- Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal
serous papillary carcinoma

- No mixed Mullerian tumors

- No borderline ovarian tumors

- Stage III or IV disease at time of diagnosis by surgical staging

- Expression of KIT (CD117) and/or platelet-derived growth factor receptor by

- Relapsed within 6 months after completion of or progressed while receiving prior
frontline chemotherapy with a platinum (cisplatin or carboplatin) and a
taxane(paclitaxel or docetaxel) administered concurrently or sequentially

- Measurable disease

- Performance status - Zubrod 0-1

- Absolute neutrophil count at least 1,500/mm^3

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

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN

- Creatinine no greater than 1.5 times ULN

- No New York Heart Association class III or IV heart disease (e.g., congestive heart
failure or myocardial infarction within the past 2 months)

- Not pregnant or nursing

- Negative pregnancy test

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

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately
treated stage I or II cancer in complete remission

- At least 28 days since prior biologic therapy

- No concurrent anticancer biologic therapy

- No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

- At least 28 days since prior chemotherapy

- No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy

- Retreatment with a platinum agent or with the same taxane as in the frontline
regimen is not counted as an additional regimen

- No concurrent chemotherapy

- Prior hormonal therapy allowed

- Recovered from prior radiotherapy

- No prior radiotherapy to more than 25% of bone marrow

- No concurrent radiotherapy

- Prior surgical debulking allowed for relapsed disease if measurable disease remains
after surgery

- At least 14 days since prior major surgery

- Recovered from all prior surgery

- At least 28 days since prior investigational drugs

- No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose
warfarin (1 mg/day) allowed)

- No other concurrent anticancer agents

- No other concurrent investigational drugs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial confirmed response)

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

David Alberts

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Southwest Oncology Group (SWOG) Research Base San Antonio, Texas  78245