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

Cervical Cancer Clinical Trial

Official title:

A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00138151
• Other study ID #: CDR0000433516
• Secondary ID: P30CA072720CINJ-
• Status: Terminated
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: September 17, 2013
• Start date: March 2001
• Est. completion date: November 2010

Study information

• Verified date: September 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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
• paclitaxel
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	UMDNJ University Hospital	Newark	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (Complete and Partial)	All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.	8 years	No
Secondary	The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.		8 years	No
Secondary	The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.		8 years	No