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A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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 HospitalMorristown, New Jersey  07962
UMDNJ University HospitalNewark, New Jersey  07103
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903