Spots Global Cancer Trial Database for Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
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Trial Identification
Brief Title: Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Official Title: A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
Study ID: NCT00138151
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed. PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
Detailed Description: OBJECTIVES: * Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel. OUTLINE: This is a multicenter study. Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
UMDNJ University Hospital, Newark, New Jersey, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: Lorna Rodriguez, MD, PhD
Affiliation: Rutgers Cancer Institute of New Jersey
Role: PRINCIPAL_INVESTIGATOR
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