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A Phase IIA Trial of Continuous Five Day Infusions of MSI-1256F (Squalamine Lactate) Plus Carboplatin for Therapy of Refractory and Resistant Stage III and IV Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

A Phase IIA Trial of Continuous Five Day Infusions of MSI-1256F (Squalamine Lactate) Plus Carboplatin for Therapy of Refractory and Resistant Stage III and IV Ovarian Cancer

OBJECTIVES: I. Determine the response rate and time to progression in patients with
recurrent or refractory stage III or IV ovarian cancer treated with squalamine lactate and
carboplatin. II. Determine the safety profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 15-30 minutes on day 1 and squalamine lactate
IV continuously on days 1-5. Treatment repeats every 3 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed at approximately 1

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer
Refractory disease Progression on prior primary paclitaxel and carboplatin OR Resistant
disease Recurrence within 12 months of initial response after completion of prior
paclitaxel and carboplatin Recurrence within 12 months of initial response to a prior
secondary or tertiary regimen allowed Bidimensionally measurable or evaluable disease OR
Elevated CA125 level CA125 at least 100 U/mL (risen from prior lower levels) OR CA125
greater than 50 U/mL but less than 100 U/mL (at least doubled from prior lower levels) No
known brain metastases unless clinically stable after treatment with prior surgery and/or

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR SWOG 0-1 Life
expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than 2 times upper limit of normal (ULN) AST less than 5 times ULN Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No
significant cardiac disease No uncontrolled high blood pressure No unstable angina No
congestive heart failure No myocardial infarction within the past year No serious cardiac
arrhythmia requiring medication Other: No clinically significant neuropathy No other
active malignancy No uncontrolled serious active infection No uncontrolled diabetes
mellitus No other condition that would preclude study Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for at least
30 days after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological response modifiers No
prior anti-angiogenesis agents No prior squalamine lactate No concurrent growth factors,
except for epoetin alfa Chemotherapy: See Disease Characteristics Received 1-3 prior
chemotherapy regimens for ovarian cancer At least 5 years since prior chemotherapy for
other malignancy Endocrine therapy: Concurrent hormonal therapy allowed if therapy
initiated at least 6 months prior to study Radiotherapy: See Disease Characteristics
Recovered from prior radiotherapy At least 5 years since prior radiotherapy for other
malignancy No prior radiotherapy to only area of measurable or evaluable disease unless
that site had subsequent disease progression Concurrent localized radiotherapy for pain or
symptom relief allowed if other methods are ineffective and measurable and/or evaluable
disease remains outside the radiotherapy portals Surgery: See Disease Characteristics
Other: At least 30 days since prior investigational therapy No prior enrollment in this
study No other concurrent antitumor treatment No other concurrent investigational therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Linnea Chap, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • ovarian stromal cancer
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • Ovarian Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781