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

September 17, 2013 updated by: University of Medicine and Dentistry of New Jersey

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Cancer Institute of New Jersey At Hamilton
      • Morristown, New Jersey, United States, 07962
        • Carol G. Simon Cancer Center at Morristown Memorial Hospital
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, United States, 08903
        • Saint Peter's University Hospital
      • Newark, New Jersey, United States, 07103
        • UMDNJ University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:

    • Stage IVB disease
    • Recurrent disease
    • Persistent disease
  • Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression
  • Measurable disease by physical exam or radiographic studies
  • Not amenable to chemoradiotherapy or surgery

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC ≥ 3,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT and SGPT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No active infection
  • No medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interferon
  • No other concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy)
  • No other prior chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy for cancer

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Recovered from prior surgery
  • No concurrent surgery for cancer

Other

  • No prior retinoids
  • No other concurrent anticancer therapy
  • No other concurrent experimental agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paclitaxel, 13-cis Retinoic Acid, and 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Complete and Partial)
Time Frame: 8 years
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Time Frame: 8 years
8 years
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lorna Rodriguez, MD, PhD, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (ESTIMATE)

August 30, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000433516
  • P30CA072720 (U.S. NIH Grant/Contract)
  • CINJ-100101 (OTHER: Cancer Institute of New Jersey)
  • CINJ-3390 (OTHER: Cancer Institute of New Jersey)
  • CINJ-NJ1703 (OTHER: Cancer Institute of New Jersey)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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