Isotretinoin, Interferon Alfa-2b, and Paclitaxel in Treating Patients With Stage IV, Recurrent, or Persistent Cervical Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer
Intervention: isotretinoin (Drug); paclitaxel (Drug); recombinant interferon alfa (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cancer Institute of New Jersey Official(s) and/or principal investigator(s):
Lorna Rodriguez, MD, PhD, Principal Investigator, Affiliation: 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 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.
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: Treatment, Open Label
Primary outcome: Response rate (complete and partial)
Detailed description:
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.
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; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey at Ham, Phone: 609-631-6946
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey 07962, United States; Recruiting
Contact Person, Phone: 973-971-6100
Saint Peter's University Hospital, New Brunswick, New Jersey 08903, United States; Recruiting
Contact Person, Phone: 732-745-8600
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Clinical Trials Office - Hospital of the University of Pennsyl, Phone: 215-746-7406
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2001
Last updated: October 17, 2008
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