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Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy Clinical research trials and Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy clinical trial. Subjects frequently obtain the most expert healthcare possible for their Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy  Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
For Condition: recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Marimastat may stop the growth of breast cancer by stopping blood flow to the tumor. It is not known whether chemotherapy is more effective with or without marimastat for breast cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of marimastat with that of no further therapy in treating women who have metastatic breast cancer that is responding or stable after chemotherapy.
Details: OBJECTIVES: I. Determine whether marimastat prolongs progression-free survival in patients with metastatic breast cancer who have responding or stable disease after receiving standard systemic chemotherapy. II. Determine the toxic effects of marimastat compared with placebo in patients with metastatic breast cancer who have responding or stable disease after receiving standard systemic chemotherapy. III. Determine whether there is an association between trough marimastat concentration and time to disease progression and toxicity. PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified by the number of involved disease sites at study entry, prior chemotherapy for metastases, osseous disease only at study entry, and bisphosphonate therapy at study entry, and concurrent hormonal therapy (yes vs no). Patients are randomized into two groups. Patients take either marimastat or placebo, one capsule orally twice a day, approximately every 12 hours (i.e., during or after breakfast and dinner). The drug or placebo is given until the development of progressive disease or prohibitive toxicity. PROJECTED ACCRUAL: A total of 334 patients will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the breast with previous manifestations of progressing regional or metastatic cancer - Received one prior systemic chemotherapy regimen for the treatment of metastases, which meets all of the following criteria: Included either doxorubicin, a taxane (i.e., paclitaxel or docetaxel), or both 6-8 courses were given; If weekly taxane therapy received, at least 12 doses were given; Recovered from all related toxic effects (except alopecia and/or neuropathy) 3-6 weeks have elapsed since last course of chemotherapy was given; No more than 40 weeks have elapsed since the first dose of chemotherapy for metastases - No current or prior history of brain metastases - Responding or stable disease since the initiation of systemic chemotherapy (i.e., no disease progression) required - No prior enrollment on ECOG trials for metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy; No prior trastuzumab - Chemotherapy: See Disease Characteristics; No concurrent chemotherapy; No prior marimastat or batimastat - Endocrine therapy: Prior and/or concurrent hormonal therapy for breast cancer allowed; Concurrent hormonal therapy allowed - Radiotherapy: No concurrent radiotherapy - Surgery: No prior organ allograft - Other: At least 4 weeks since other investigational agents; No concurrent bisphosphonate therapy unless it was initiated prior to the study; No concurrent immunosuppressive therapy; Patients receiving anticoagulant therapy must be carefully monitored --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal Status: Not specified - Performance status: ECOG 0 or 1 - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater 2 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test required if pre- or peri-menopausal (i.e., last menstrual period within one year prior to study); Pre- or peri-menopausal sexually active women must use effective contraception; No other invasive malignancy within last 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; No history of rheumatoid arthritis, osteoarthritis, symptomatic osteoarthritis requiring therapy, or other inflammatory arthritis; At least 5 years since prior invasive malignancies except: Curatively treated basal cell or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephSparano, Study Chair, Eastern Cooperative Oncology Group
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Additional Information:
Study ID Numbers: CDR0000065585; E-2196
Study Start Date: September 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003010
Other Recurrent Breast Cancer Studies:
1. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
2. Bexarotene in Treating Patients With Metastatic Breast Cancer
3. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
4. Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
5. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other North Dakota Clinical Trials
Other Grand Forks Clinical Trials
Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
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