Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
- Conditions
- Cervical Cancer
- Interventions
- Registration Number
- NCT00138151
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b recombinant interferon alpha-2b * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b isotretinoin * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b paclitaxel * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
- Primary Outcome Measures
Name Time Method Response Rate (Complete and Partial) 8 years All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
- Secondary Outcome Measures
Name Time Method The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels. 8 years The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens. 8 years
Trial Locations
- Locations (6)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UMDNJ University Hospital
🇺🇸Newark, 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
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States