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

University of Medicine and Dentistry of New Jersey

Status and phase: Terminated; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: isotretinoin; Biological: recombinant interferon alpha-2b; Drug: paclitaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00138151

CINJ-3390 (Other Identifier)

CINJ-100101 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

CDR0000433516

CINJ-NJ1703 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b

Experimental group

Description:

* 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

Treatment:

Drug: paclitaxel

Biological: recombinant interferon alpha-2b

Drug: isotretinoin