Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Isotretinoin, Interferon alfa-2b, and Paclitaxel in Treating Patients With Stage IV, Recurrent, or Persistent Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	CINJ-100101 NJ 1703, CINJ-3390, CINJ-NJ1703, NCT00138151

Objectives

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

Entry 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

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

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• WBC ≥ 3,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 27-66 patients will be accrued for this study.

Outcomes

Response rate (complete and partial)

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Lorna Rodriguez, MD, PhD, Principal investigator		Ph: 732-235-8521 Email: deleonli@umdnj.edu

U.S.A.
New Jersey
	Hamilton
	Cancer Institute of New Jersey at Hamilton
		Clinical Trials Office - Cancer Institute of New Jersey at Hamilton	Ph:  609-631-6946
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Contact Person	Ph:  973-971-6100 800-247-9580
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Saint Peter's University Hospital
		Contact Person	Ph:  732-745-8600

Registry Information
Official Title		A Phase II Trial of Chemosensitization with Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
Trial Start Date		2001-03-01
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00138151
Date Submitted to PDQ		2005-05-16
Information Last Verified		2009-06-26
NCI Grant/Contract Number		CA72720

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