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Phase II CT-2103/Carboplatin in Ovarian Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Phase II CT-2103/Carboplatin in Ovarian Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II CT-2103/Carboplatin in Ovarian Cancer Clinical research trials and Phase II CT-2103/Carboplatin in Ovarian Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase II CT-2103/Carboplatin in Ovarian Cancer. Phase II CT-2103/Carboplatin in Ovarian Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Phase II CT-2103/Carboplatin in Ovarian Cancer clinical trial. Human subjects often get the best healthcare possible for their Phase II CT-2103/Carboplatin in Ovarian Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II CT-2103/Carboplatin in Ovarian Cancer  Phase II CT-2103/Carboplatin in Ovarian Cancer
Phase II CT-2103/Carboplatin in Ovarian Cancer
For Condition: Ovarian Neoplasm
Status: Recruiting
Sponsor(s): Cell Therapeutics ,
Synopsis: The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.
Details: CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion criteria: - Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma. - Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery. - ECOG performance score of 0, 1, or 2. - absolute neutrophil count (ANC) at least 1,500/µL. - platelet at least 100,000/µL. - hemoglobin at least 10 g/dL. - creatinine no greater than 1.5 times the upper limit of normal (ULN). - bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN. - Alkaline phosphatase no greater than 2.5 x ULN. Exclusion: - Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) - Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas. - Synchronous primary endometrial cancer or history of primary endometrial cancer. - Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above. - Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study. - Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease. - Prior radiotherapy to any portion of the abdominal cavity or pelvis. - Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease. - Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks. - Presence of active hepatitis, either acute or chronic. - Presence of active infection requiring antibiotic or antiviral therapy. - Pregnant women or nursing mothers.
Total Enrollment: 60
Location and Contact Information:
Stockton Hematology Oncology Medical *Recruiting*
Stockton, California, 95204
United States
Recruiting
Guthrie Foundation for Education and Research *Recruiting*
Sayre, Pennsylvania, 18840
United States
Recruiting
Pacific Gynecology Specialists *Recruiting*
Seattle, Washington, 98104
United States
Recruiting
Gynecology Oncology Associates *Recruiting*
Greenbrae, California,
United States
Recruiting
Aurora Health Care, Inc. *Recruiting*
Milwaukee, Wisconsin, 53201
United States
Recruiting
University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting
Albert Einstein Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19141
United States
Recruiting
Upstate New York Cancer Research and Education Foundation *Recruiting*
Rochester, New York, 98104
United States
Recruiting
California Cancer Care *Recruiting*
Greenbrae, California, 94904
United States
Recruiting
Gynecology, Oncology, and Pelvic Surgery Associates, Inc. *Recruiting*
Columbus, Ohio, 43222
United States
Recruiting
Swedish Cancer Institute *Recruiting*
Seattle, Washington, 98104
United States
Recruiting
Arlington Fairfax Hematology Oncology *Recruiting*
Arlington, Virginia, 22205
United States
Recruiting
Baptist Regional Cancer Center *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting
Raben and Fldman Research Associates *Recruiting*
Miami, Florida, 33143
United States
Recruiting
South Carolina Oncology Assoicates *Recruiting*
Columbia, South Carolina, 29203
United States
Recruiting
Chattanooga GYN-Oncology *Recruiting*
Chattanooga, Tennessee, 37403
United States
Recruiting
Resource Center for Gynecology/ Oncology *Recruiting*
Kansas City, Missouri, 64132
United States
Recruiting
Additional Information:
Study ID Numbers: PGT201;
Study Start Date: February 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069901
Other Ovarian Neoplasm Studies:
1. Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein
2. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
3. Phase II CT-2103/Carboplatin in Ovarian Cancer
4. A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin with G-CSF for Patients with Newly Diagnosed Advanced Stage Ovarian Cancer
5. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
Other Ovarian Neoplasm Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Phase II CT-2103/Carboplatin in Ovarian Cancer
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