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

NCT00138151 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-11-20

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Lorna Rodriguez, MD, PhD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00138151 on ClinicalTrials.gov