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

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 alfa-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 alfa-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: December 2008

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

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.

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

Intervention(s) in this Clinical Trial

• Drug: isotretinoin
• Drug: paclitaxel
• Drug: recombinant interferon alfa

Primary Measures

• Response rate (complete and partial)
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer Institute of New Jersey

Overall Clinical Trial Officials and Contacts

Lorna Rodriguez, MD, PhD Principal Investigator Cancer Institute of New Jersey  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00138151

Study ID Number: CDR0000433516

ClinicalTrials.gov Identifier: NCT00138151

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database