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

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Cancer

Intervention: recombinant interferon alpha-2b (Biological); isotretinoin (Drug); paclitaxel (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of Medicine and Dentistry of New Jersey

Official(s) and/or principal investigator(s):
Lorna Rodriguez, MD, PhD, Principal Investigator, Affiliation: Rutgers Cancer Institute of New Jersey

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.

Clinical Details

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

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

Primary outcome: Response Rate (Complete and Partial)

Secondary outcome:

The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.

The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey 08690, United States

Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey 07962, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Saint Peter's University Hospital, New Brunswick, New Jersey 08903, United States

UMDNJ University Hospital, Newark, New Jersey 07103, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Additional Information

Starting date: March 2001
Last updated: September 17, 2013

Page last updated: August 23, 2015

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