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Sponsored by: |
Cancer Institute of New Jersey |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00138151 |
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 alfa-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 alfa-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: isotretinoin Drug: paclitaxel Drug: recombinant interferon alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Chemosensitization With Paclitaxel, 13-Cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma |
Estimated Enrollment: | 66 |
Study Start Date: | March 2001 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alfa-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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | Recruiting |
Hamilton, New Jersey, United States, 08690 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
Morristown, New Jersey, United States, 07962 | |
Contact: Contact Person 973-971-6100 | |
Saint Peter's University Hospital | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Contact Person 732-745-8600 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Clinical Trials Office - Hospital of the University of Pennsyl 215-746-7406 |
Principal Investigator: | Lorna Rodriguez, MD, PhD | Cancer Institute of New Jersey |
Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Lorna Rodriguez ) |
Study ID Numbers: | CDR0000433516, CINJ-100101, CINJ-3390, CINJ-NJ1703 |
Study First Received: | August 29, 2005 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00138151 |
Health Authority: | Unspecified |
recurrent cervical cancer stage IVB cervical cancer |
Interferon-alpha Interferon Type I, Recombinant Paclitaxel Interferons Isotretinoin |
Tretinoin Interferon Alfa-2a Interferon Alfa-2b Recurrence Carcinoma |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Tubulin Modulators Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents, Phytogenic Dermatologic Agents |