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Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Clinical research trials and Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer. Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer  Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer
Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer
For Condition: recurrent ovarian epithelial cancer,stage 3 ovarian epithelial cancer,ovarian endometrioid adenocarcinoma,stage 4 ovarian epithelial cancer,ovarian undifferentiated adenocarcinoma
Status: Suspended
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as cBR96-doxorubicin immunoconjugate (SGN-15) may be able to locate tumor cells and kill them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cBR96-doxorubicin immunoconjugate in treating ovarian cancer. PURPOSE: Randomized phase II trial to study the effectiveness of gemcitabine with or without cBR96-doxorubicin immunoconjugate in treating patients who have recurrent or persistent stage III or stage IV ovarian epithelial cancer.
Details: OBJECTIVES: - Determine the toxicity and safety profile of cBR96-doxorubicin immunoconjugate (SGN-15) in combination with gemcitabine in patients with recurrent or persistent ovarian epithelial adenocarcinoma. - Compare the progression-free survival of these patients treated with gemcitabine with or without SGN-15. - Compare the clinical response rate of patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are stratified according to Lewis^y antigen expression (greater than 50% vs no greater than 50%). The first cohort of 6 patients receive 1 full course of treatment to evaluate safety. - Safety cohort: Patients receive cBR96-doxorubicin immunoconjugate (SGN-15) IV over 2 hours and gemcitabine IV over 30 minutes once weekly. Treatment continues for 3 weeks followed by 1 week of rest. If no dose-limiting toxicity is observed during this course, patients receive an increased dose of SGN-15 for all subsequent courses, up to a total of 12. Subsequent patients are randomized into 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes and SGN-15 IV over 2 hours on days 1, 8, and 15. - Arm II: Patients receive gemcitabine as in arm I. Patients with progressive disease after 2 full courses of therapy may cross over to arm I. In both arms, treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 3 years and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 6-76 patients (6 for the safety cohort, 47 for arm I, and 23 for arm II) will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or persistent ovarian epithelial adenocarcinoma - Stage III or IV - Lewis^y antigen expression at least 20% by immunohistochemistry on archived or fresh tumor specimen - Measurable disease with at least 1 target lesion - Must have platinum-resistant disease as defined by 1 of the following: - Progression while on initial platinum therapy - Progression while on retreatment with initial platinum regimen - Relapse no more than 6 months after initial platinum therapy - No brain metastases that are not controlled and/or require active treatment (including corticosteroids) - Spinal cord metastatic lesions allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - No bleeding dyscrasia Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Amylase no greater than 1.5 times ULN - Lipase no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN - Hepatitis B and C negative - No hepatic failure Renal - Creatinine no greater than 1.5 times ULN - No renal failure Cardiovascular - LVEF at least 50% by echocardiogram or MUGA - No congestive heart failure Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Accessible for follow-up - No prior allergic reaction to recombinant human or murine proteins - No other primary malignancy except nonmelanoma skin cancer - No serious nonmalignant disease - No uncontrolled peptic ulcer disease - No grade 2 or greater peripheral neuropathy - No active viral, bacterial, or systemic fungal infection - No other serious underlying medical condition that would preclude study participation - No dementia or altered mental status that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - At least 6 months since prior therapeutic monoclonal antibody unless recent serum testing reveals no antibody against cBR96 Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No prior gemcitabine - No cumulative anthracycline exposure equal to or greater than 300 mg/m^2 - No more than 3 prior systemic chemotherapy regimens for ovarian cancer - Retreatment with taxane/platinum after initial combination is considered only 1 regimen Endocrine therapy - See Disease Characteristics - No concurrent hormonal therapy for appetite stimulation Radiotherapy - At least 4 weeks since prior radiotherapy, including whole abdomen, abdominopelvic, or pelvic Surgery - At least 4 weeks since prior surgery Other - No other concurrent antineoplastic agents - No other concurrent experimental agents - No other concurrent immunosuppressive medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanBerek, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000271918; SGEN-SG015-0003,UCLA-0210039
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056017
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
2. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
3. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
4. Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
5. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer
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