Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carboplatin
Squalamine
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

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