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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.
Study NCT00138151   Information provided by National Cancer Institute (NCI)
First Received: August 29, 2005   Last Updated: June 27, 2009   History of Changes

August 29, 2005
June 27, 2009
March 2001
December 2008   (final data collection date for primary outcome measure)
Response rate (complete and partial) [ Designated as safety issue: No ]
Response rate (complete and partial)
Complete list of historical versions of study NCT00138151 on ClinicalTrials.gov Archive Site
 
 
 
Isotretinoin, Interferon Alfa-2b, and Paclitaxel in Treating Patients With Stage IV, Recurrent, or Persistent Cervical Cancer
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 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.

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.

Phase II
Interventional
Treatment, Open Label
Cervical Cancer
  • Biological: recombinant interferon alfa
  • Drug: isotretinoin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
66
 
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
 
United States
 
NCT00138151
Lorna Rodriguez, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
CDR0000433516, CINJ-100101, CINJ-3390, CINJ-NJ1703
Cancer Institute of New Jersey
 
Principal Investigator: Lorna Rodriguez, MD, PhD Cancer Institute of New Jersey
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP