Clinical trial NCT00138151: Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Official title: A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: recurrent cervical cancer
stage IVB cervical cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-08-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 alpha-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 alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.

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 multicenter study.

Patients receive oral isotretinoin and interferon alpha-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 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

Primary outcomes:
measure: Response Rate (Complete and Partial)
timeFrame: 8 years
Secondary outcomes:
measure: The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
timeFrame: 8 years
measure: The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
timeFrame: 8 years
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Morristown
country: United States
facility: Carol G. Simon Cancer Center at Morristown Memorial Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: UMDNJ University Hospital
state: New Jersey
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Lorna Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: