Isotretinoin, Interferon Alfa-2b, and Paclitaxel in Treating Patients With Stage IV, Recurrent, or Persistent Cervical Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Biological: recombinant interferon alfa Drug: isotretinoin Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma |
- Response rate (complete and partial) [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | March 2001 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | 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
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| UMDNJ University Hospital | |
| Newark, New Jersey, United States, 07103 | |
| Principal Investigator: | Lorna Rodriguez, MD, PhD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lorna Rodriguez, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
| ClinicalTrials.gov Identifier: | NCT00138151 History of Changes |
| Other Study ID Numbers: | CDR0000433516, P30CA072720, CINJ-100101, CINJ-3390, CINJ-NJ1703 |
| Study First Received: | August 29, 2005 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
recurrent cervical cancer stage IVB cervical cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Reaferon Paclitaxel |
Isotretinoin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013