Status:
TERMINATED
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 chemo...
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 multicent...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00138151
Start Date
March 1 2001
End Date
November 1 2010
Last Update
November 20 2013
Active Locations (6)
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1
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
2
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
3
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
4
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903