Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT00021385 |
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Recruitment Status : Unknown
Verified May 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 4, 2004
Last Update Posted : December 18, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Drug: carboplatin Drug: squalamine lactate | Phase 2 |
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 month.
PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | May 2001 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021385
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Linnea Chap, MD | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00021385 |
| Other Study ID Numbers: |
CDR0000068774 UCLA-0001004 MAGA-MSI-1256F-203 NCI-G01-1987 |
| First Posted: | February 4, 2004 Key Record Dates |
| Last Update Posted: | December 18, 2013 |
| Last Verified: | May 2002 |
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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 |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Squalamine Carboplatin Antineoplastic Agents Anti-Bacterial Agents Anti-Infective Agents Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |