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A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Inclusion Criteria:

- At least 18 years of age

- Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or
primary peritoneal carcinoma

- Completion of only one previous course of chemotherapy which contained a platinum
therapy, with resistance to that regimen. "Platinum-resistance" is defined by a
relapse within 2 to 6 months after termination of platinum-based chemotherapy

- Measurable disease, defined by at least one lesion that can be accurately measured in
at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when
measured by conventional techniques (palpation, plain x-ray, computed tomography
[CT], or magnetic resonance imaging [MRI]) or ≥ 10 mm when measured by spiral CT

- Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3,
platelets ≥ 100,000/mm3, creatinine clearance > 50mL/min, alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; or < 5
x ULN in case of liver metastases); total bilirubin < 1.5 mg/dL

- For women of child bearing potential, documented negative pregnancy test within two
weeks of study entry and agreement to acceptable birth control during the duration of
the study therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Signed, institutional review board (IRB) approved written informed consent

Exclusion Criteria:

- Concurrent invasive malignancy, not including:

1. Non-melanomatous skin cancer

2. In situ malignancies

3. Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is
superficial or invades less than 50% the thickness of the myometrium)

4. Low risk breast cancer (localized, non-inflammatory) treated with curative

- Lesions identifiable only by positron emission tomography (PET)

- Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including

- Major medical conditions that might affect study participation (i.e., uncontrolled
pulmonary, renal, or hepatic dysfunction, uncontrolled infection)

- Other significant co-morbid condition which the investigator feels might compromise
effective and safe participation in the study, including a history of congestive
cardiac failure or an electrocardiogram (ECG) suggesting significant conduction
defect or myocardial ischemia

- Enrollment in another investigational device or drug study, or current treatment with
other investigational agents

- Concurrent radiation therapy to treat primary disease throughout the course of the

- Inability to comply with the requirements of the study

- Pregnancy or lactation

- Leptomeningeal disease or brain metastases requiring steroids or other therapeutic

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201

Outcome Time Frame:

Until progressive disease or death

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cancer
  • ovarian
  • cancer
  • sensitive
  • PARP
  • recurrent
  • platinum-resistant recurrent ovarian cancer
  • Ovarian Neoplasms



Massachusetts Ceneral HospitalBoston, Massachusetts  02114