Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0001004 MAGA-MSI-1256F-203, NCI-G01-1987, NCT00021385

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.

Entry 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 radiotherapy

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

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

Expected Enrollment

Approximately 45 patients will be accrued for this study.

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 month.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Linnea Chap, MD, Protocol chair		Ph: 310-206-6144; 888-798-0719

Registry Information
Official Title		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
Trial Start Date		2001-05-22
Registered in ClinicalTrials.gov		NCT00021385
Date Submitted to PDQ		2001-05-29
Information Last Verified		2002-05-01
NCI Grant/Contract Number		P30-CA16042

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