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

This study has been terminated.
(Slow accrual and lack of study drug)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00138151
First received: August 29, 2005
Last updated: September 17, 2013
Last verified: September 2013
  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 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.


Condition Intervention Phase
Cervical Cancer
Biological: recombinant interferon alpha-2b
Drug: isotretinoin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Response Rate (Complete and Partial) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: March 2001
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138151

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
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Lorna Rodriguez, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
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
Results First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
recurrent cervical cancer
stage IVB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Interferon-alpha
Interferons
Isotretinoin
Paclitaxel
Tretinoin
Anti-Infective Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Dermatologic Agents
Immunologic Factors
Keratolytic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014