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Isotretinoin, Interferon Alfa-2b, and Paclitaxel in Treating Patients With Stage IV, Recurrent, or Persistent Cervical Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: August 29, 2005   Last Updated: June 27, 2009   History of Changes
Sponsored by: Cancer Institute of New Jersey
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00138151
  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 alfa-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 alfa-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Biological: recombinant interferon alfa
Drug: isotretinoin
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial) [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: March 2001
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alfa-2b, and paclitaxel.

OUTLINE: This is a multicenter study.

Patients receive oral isotretinoin and interferon alfa-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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138151

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham     609-631-6946        
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Carol G. Simon Cancer Center at Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Contact Person     973-971-6100        
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Contact Person     732-745-8600        
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: Lorna Rodriguez, MD, PhD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Lorna Rodriguez )
Study ID Numbers: CDR0000433516, CINJ-100101, CINJ-3390, CINJ-NJ1703
Study First Received: August 29, 2005
Last Updated: June 27, 2009
ClinicalTrials.gov Identifier: NCT00138151     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
stage IVB cervical cancer

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Immunologic Factors
Interferons
Antimitotic Agents
Antiviral Agents
Angiogenesis Inhibitors
Recurrence
Carcinoma
Paclitaxel
Tubulin Modulators
Isotretinoin
Tretinoin
Interferon Alfa-2a
Antineoplastic Agents, Phytogenic
Interferon Alfa-2b

Additional relevant MeSH terms:
Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Interferons
Physiological Effects of Drugs
Antimitotic Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Isotretinoin
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a
Antineoplastic Agents, Phytogenic
Dermatologic Agents
Interferon Alfa-2b

ClinicalTrials.gov processed this record on July 02, 2009