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Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alpha-2b
isotretinoin
paclitaxel
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at Hamilton
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Saint Peter's University Hospital
  • UMDNJ University Hospital
  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b

Arm Description

Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Outcomes

Primary Outcome Measures

Response Rate (Complete and Partial)
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.

Secondary Outcome Measures

The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.

Full Information

First Posted
August 29, 2005
Last Updated
September 17, 2013
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00138151
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual and lack of study drug
Study Start Date
March 2001 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Arm Type
Experimental
Arm Description
Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alpha-2b
Intervention Description
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Intervention Description
Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
Primary Outcome Measure Information:
Title
Response Rate (Complete and Partial)
Description
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Time Frame
8 years
Secondary Outcome Measure Information:
Title
The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Time Frame
8 years
Title
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Time Frame
8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna Rodriguez, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
UMDNJ University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

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