RATIONALE: Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining squalamine lactate with carboplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining squalamine lactate and carboplatin in treating patients who have recurrent or refractory stage III or stage IV ovarian cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian germ cell tumor recurrent ovarian epithelial cancer stage III ovarian germ cell tumor stage IV ovarian germ cell tumor stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian stromal cancer ovarian low malignant potential tumor ovarian sarcoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Drug: carboplatin  Drug: squalamine lactate	Phase II

Further Study Details: 

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.

PROTOCOL 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.

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

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

Study chairs or principal investigators

Linnea Chap,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068774; UCLA-0001004; NCI-G01-1987; MAGA-MSI-1256F-203
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021385
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08