A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
18 Years
N/A
Female
Cervical Cancer
Trial Information
A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (complete and partial)
Safety Issue:
No
Principal Investigator
Lorna Rodriguez, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000433516
NCT ID:
NCT00138151
Start Date:
March 2001
Completion Date:
December 2009
Related Keywords:
- Cervical Cancer
- recurrent cervical cancer
- stage IVB cervical cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| UMDNJ University Hospital | Newark, New Jersey 07103 |
| Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
| Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
