NCT00138151

Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alpha-2b	Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
DRUG	isotretinoin	Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
DRUG	paclitaxel	Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Timeline

• Start date: 2001-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2005-08-30
• Last updated: 2013-11-20
• Results posted: 2013-11-20

Locations

6 sites across 1 country: United States