NCT00138151

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed
Last Updated

November 20, 2013

Status Verified

September 1, 2013

Enrollment Period

9.7 years

First QC Date

August 29, 2005

Results QC Date

September 17, 2013

Last Update Submit

September 17, 2013

Conditions

Cervical Cancer

Keywords

recurrent cervical cancerstage IVB cervical cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 years

Secondary Outcomes (2)

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

    8 years

  • The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.

    8 years

Study Arms (1)

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

EXPERIMENTAL

* 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

Biological: recombinant interferon alpha-2bDrug: isotretinoinDrug: paclitaxel

Interventions

recombinant interferon alpha-2bBIOLOGICAL

Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle

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

Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle

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

Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

UMDNJ University Hospital

Newark, New Jersey, 07103, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Interferon alpha-2IsotretinoinPaclitaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalTaxoidsCyclodecanesDiterpenes

Results Point of Contact

Title
Lorna Rodriguez, MD, PhD
Organization
Rutgers Cancer Institute of New Jersey
rodriglo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
732-235-8675

Study Officials

  • Lorna Rodriguez, MD, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

March 1, 2001

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 20, 2013

Results First Posted

November 20, 2013

Record last verified: 2013-09

Locations

US(6)