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A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical research trials and A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer  A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
For Condition: Fallopian Tube Neoplasm,Ovarian Neoplasm,Peritoneal Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: CAI, an orally administered anti-angiogenic, anti-invasive drug that inhibits nonvoltage-gated calcium influx has been shown to inhibit ovarian cancer progression in xenograft models and to stabilize disease of epithelial ovarian cancer patients in the phase I dose escalation trial. The objectives of this clinical trial are to determine the potential clinical activity of CAI in relapsed and refractory ovarian cancer patients and to investigate clinico-laboratory correlates of its anti-angiogenic and anti-signaling activity.
Details: CAI, an orally administered anti-angiogenic, anti-invasive drug that inhibits nonvoltage-gated calcium influx has been shown to inhibit ovarian cancer progression in xenograft models and to stabilize disease of epithelial ovarian cancer patients in the phase I dose escalation trial. The objectives of this clinical trial are to determine the potential clinical activity of CAI in relapsed and refractory ovarian cancer patients and to investigate clinico-laboratory correlates of its anti-angiogenic and anti-signaling activity.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA Patients with persistent, recurrent, or relapsed epithelial ovarian cancer are eligible. Patients with pathologically confirmed (within LP, DCS, NCI) epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma are eligible. Patients must have measurable disease by physical examination, radiographic studies, or on peritoneoscopy or laparotomy. Patients with measurable disease by peritoneoscopy must initiate treatment within 4 weeks of surgery and be willing to have a repeat procedure to document stabilization. Patients who have received only three prior treatment regimens; Patients must have ECOG performance status 0, 1, or 2; Patients must have life expectancy of 4 months or greater; End organ parameters: serum creatinine is less than or equal to 1.5 or creatinine clearance is greater than or equal to 50 cc/min; ANC is greater than or equal to 1000/cm(3); platelet count is greater than or equal to 100,000/cm(3); Hb is greater than or equal to 9.0 gm/dl and/or Hct is greater than or equal to 27 mg percent; SGOT/SGPT is less than or equal to 3 times upper normal limit, bili is within normal limits. Patients must be 4 plus weeks from completion of prior chemotherapy (6 weeks for mitomycin C, nitrosoureas), radiation therapy, hormonal therapy, or cytokine therapy. Patients must be at least one week from the completion of systemic antibiotics for infection. Patient must be able to take oral medication. Patient must be able to give informed consent. Patient must be greater than or equal to 18 years of age. EXCLUSION CRITERIA Intercurrent medical condition, e.g., impending bowel obstruction. Patients with grade 2 or greater residual peripheral neuropathy will not be eligible until resolution to grade 1 or better. Patients with active infection, including positive serology for HIV are not eligible. Patients requiring chronic anti-fungal treatment with anti-mycotic imidazoles are not eligible. Patients requiring corticosteroids at doses greater than physiologic replacement doses. Patients with recent history of symptomatic cardiac dysrhythmias requiring continuing medication. Patients with recent history (within 6 months) of a myocardial infarction, unstable or newly diagnosed angina; chronic obstructive lung disease requiring oxygen therapy; Patients with concomitant chemotherapy, radiation therapy, cytokine, or hormonal therapy, or alternative therapies. Patients who require cytokine therapy to maintain leukocyte count. Patients with history or presence of invasive malignancy other than ovarian, fallopian tube, or peritoneal carcinoma are not eligible (a remote history, e.g., an invasive cancer greater than 5 years prior to initiation of protocol will be allowed) Patients with a history of acute visual loss other than that associated with retinal detachment, successfully recovered. Patients with brain metastases. Patients who are pregnant and/or breastfeeding.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980012; 98-C-0012
Study Start Date: March 25, 1998
Record last reviewed: February 16, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001682
Other Peritoneal Neoplasm Studies:
1. SU5416 and Carboplatin to Treat Ovarian Cancer
2. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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