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

NCT ID: NCT00138151

Last Updated: 2013-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2010-11-30

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.

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.

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer; stage IVB cervical cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

recombinant interferon alpha-2b

Intervention Type: BIOLOGICAL

Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle

isotretinoin

Intervention Type: DRUG

Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle

paclitaxel

Intervention Type: DRUG

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

Interventions

recombinant interferon alpha-2b

Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle

Intervention Type: BIOLOGICAL

isotretinoin

Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle

Intervention Type: DRUG

paclitaxel

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorna Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ-100101

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-3390

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-NJ1703

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000433516

Identifier Type: -

Identifier Source: org_study_id