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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00138151
Recruitment Status : Terminated (Slow accrual and lack of study drug)
First Posted : August 30, 2005
Results First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2001
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens. [ Time Frame: 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138151


Locations
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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
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorna Rodriguez, MD, PhD Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00138151    
Other Study ID Numbers: CDR0000433516
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-100101 ( Other Identifier: Cancer Institute of New Jersey )
CINJ-3390 ( Other Identifier: Cancer Institute of New Jersey )
CINJ-NJ1703 ( Other Identifier: Cancer Institute of New Jersey )
First Posted: August 30, 2005    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: November 20, 2013
Last Verified: September 2013
Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
recurrent cervical cancer
stage IVB cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Paclitaxel
 Isotretinoin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents