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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00138151 |
Purpose
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 |
Biological: recombinant interferon alfa Drug: isotretinoin Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma |
| Enrollment: | 33 |
| Study Start Date: | March 2001 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (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.
Eligibility| 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
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| UMDNJ University Hospital | |
| Newark, New Jersey, United States, 07103 | |
| Principal Investigator: | Lorna Rodriguez, MD, PhD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Lorna Rodriguez, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
| ClinicalTrials.gov Identifier: | NCT00138151 History of Changes |
| Other Study ID Numbers: | CDR0000433516, P30CA072720, CINJ-100101, CINJ-3390, CINJ-NJ1703 |
| Study First Received: | August 29, 2005 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent cervical cancer stage IVB cervical cancer |
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Paclitaxel Isotretinoin |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Dermatologic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |