Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021385
First received: July 11, 2001
Last updated: December 17, 2013
Last verified: May 2002
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: squalamine lactate
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021385

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Linnea Chap, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00021385     History of Changes
Other Study ID Numbers: CDR0000068774, UCLA-0001004, MAGA-MSI-1256F-203, NCI-G01-1987
Study First Received: July 11, 2001
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Squalamine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014