Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 163 for:    ISOTRETINOIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00138151
Recruitment Status : Terminated (Slow accrual and lack of study drug)
First Posted : August 30, 2005
Results First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Cancer
Interventions Biological: recombinant interferon alpha-2b
Drug: isotretinoin
Drug: paclitaxel
Enrollment 33
Recruitment Details Subjects were recruited from 4 sites across New Jersey (2 academic medical centers and 2 community hospitals) from March 2001 through June 2009.
Pre-assignment Details  
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
Period Title: Overall Study
Started 33
Completed 29
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Physician Decision             1
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  84.8%
>=65 years
5
  15.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
53.2  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
33
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Response Rate (Complete and Partial)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Hide Description [Not Specified]
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Hide Description [Not Specified]
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 8 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Hide Arm/Group 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
All-Cause Mortality
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Affected / at Risk (%) # Events
Total   18/33 (54.55%)    
Blood and lymphatic system disorders   
Thrombosis/embolism * 1  2/33 (6.06%)  2
Hemoglobin * 1  3/33 (9.09%)  6
Vaginal bleeding * 1  1/33 (3.03%)  1
Hematuria (in the absence of vaginal bleeding) * 1  1/33 (3.03%)  1
Rectal bleeding/hematochezia * 1  1/33 (3.03%)  1
Cardiac disorders   
Hypertension * 1  1/33 (3.03%)  1
Congestive heart failure * 1  1/33 (3.03%)  2
Gastrointestinal disorders   
Dehydration * 1  2/33 (6.06%)  2
Vomiting * 1  2/33 (6.06%)  2
General disorders   
Abdominal pain * 1  3/33 (9.09%)  3
Fatigue * 1  1/33 (3.03%)  1
Fever in the absence of neutropenia where neutropenia is defined as AGC <1.0 x 10e9/L * 1  4/33 (12.12%)  4
Pain (other) - back pain * 1  4/33 (12.12%)  5
Death * 1  1/33 (3.03%)  1
Rigors/chills * 1  1/33 (3.03%)  1
Infections and infestations   
Infection without neutropenia * 1  8/33 (24.24%)  9
Infection/Febrile Neutropenia * 1  1/33 (3.03%)  1
Investigations   
Hyponatremia * 1  2/33 (6.06%)  2
Hyperkalemia * 1  1/33 (3.03%)  1
Hypocalcemia * 1  1/33 (3.03%)  1
Elevated ammonia level * 1  1/33 (3.03%)  1
Hypokalemia * 1  2/33 (6.06%)  2
Hypomagnesemia * 1  1/33 (3.03%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness (not due to neuropathy) * 1  1/33 (3.03%)  1
Fracture - neck * 1  1/33 (3.03%)  1
Cervical spinal cord compression * 1  1/33 (3.03%)  1
Nervous system disorders   
Depressed level of consciousness - somnolence * 1  1/33 (3.03%)  1
Dizziness * 1  1/33 (3.03%)  1
Change in mental status * 1  1/33 (3.03%)  1
Psychiatric disorders   
Mood alteration - anxiety, agitation * 1  1/33 (3.03%)  2
Hallucinations * 1  1/33 (3.03%)  1
Renal and urinary disorders   
Fistula or GU fistula (e.g., vaginal, vesicovaginal) * 1  1/33 (3.03%)  1
Ureteral obstruction * 1  1/33 (3.03%)  1
Dysuria * 1  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis/pulmonary infiltrates * 1  2/33 (6.06%)  2
Dypsnea * 1  1/33 (3.03%)  1
Hypoxia * 1  1/33 (3.03%)  1
Pulmonary other - respiratory failure * 1  1/33 (3.03%)  1
Vascular disorders   
Edema * 1  2/33 (6.06%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Affected / at Risk (%) # Events
Total   30/33 (90.91%)    
Blood and lymphatic system disorders   
Hemoglobin * 1  9/33 (27.27%)  16
Neutrophils/granulocytes (ANC/AGC) * 1  9/33 (27.27%)  33
Leukocytes (total WBC) * 1  7/33 (21.21%)  28
Blood/Bone Marrow-Other (Specify,_____) * 1  3/33 (9.09%)  4
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol * 1  2/33 (6.06%)  2
Cardiac disorders   
Hypertension * 1  2/33 (6.06%)  2
Endocrine disorders   
Hot flashes/flushes * 1  3/33 (9.09%)  3
Gastrointestinal disorders   
Nausea * 1  16/33 (48.48%)  33
Vomiting * 1  12/33 (36.36%)  15
Diarrhea, patients without colostomy * 1  11/33 (33.33%)  15
Constipation * 1  10/33 (30.30%)  13
Anorexia * 1  7/33 (21.21%)  9
Gastrointestinal - other * 1  6/33 (18.18%)  6
Dehydration * 1  3/33 (9.09%)  3
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1  2/33 (6.06%)  2
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol * 1  2/33 (6.06%)  2
Abdominal pain or cramping * 1  6/33 (18.18%)  6
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  19/33 (57.58%)  31
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  16/33 (48.48%)  24
Rigors, chills * 1  8/33 (24.24%)  13
Constitutional Symptoms-Other (Specify,_____) * 1  4/33 (12.12%)  6
Pain-Other (Specify,___) * 1  17/33 (51.52%)  31
Headache * 1  7/33 (21.21%)  8
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 1  2/33 (6.06%)  2
Infections and infestations   
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  2/33 (6.06%)  2
Infection without neutropenia * 1  2/33 (6.06%)  3
Infection/Febrile Neutropenia-Other (Specify,____) * 1  2/33 (6.06%)  3
Investigations   
Hypertriglyceridemia * 1  3/33 (9.09%)  3
Hypercholesterolemia * 1  2/33 (6.06%)  2
Hyperglycemia * 1  2/33 (6.06%)  2
Hyperuricemia * 1  2/33 (6.06%)  2
Hypokalemia * 1  2/33 (6.06%)  2
Musculoskeletal and connective tissue disorders   
Myalgia (muscle pain) * 1  6/33 (18.18%)  9
Arthralgia (joint pain) * 1  4/33 (12.12%)  5
Bone pain * 1  3/33 (9.09%)  4
Muscle weakness (not due to neuropathy) * 1  3/33 (9.09%)  3
Musculoskeletal-Other (Specify,______) * 1  3/33 (9.09%)  4
Nervous system disorders   
Neuropathy-sensory * 1  10/33 (30.30%)  17
Dizziness/lightheadedness * 1  3/33 (9.09%)  3
Insomnia * 1  3/33 (9.09%)  3
Neurology-Other (Specify,______) * 1  2/33 (6.06%)  2
Psychiatric disorders   
Mood alteration-anxiety, agitation * 1  4/33 (12.12%)  4
Mood alteration-depression * 1  4/33 (12.12%)  4
Renal and urinary disorders   
Renal/Genitourinary-Other (Specify,____) * 1  4/33 (12.12%)  4
Urinary frequency/urgency * 1  4/33 (12.12%)  5
Dysuria (painful urination) * 1  2/33 (6.06%)  2
Ureteral obstruction * 1  2/33 (6.06%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  5/33 (15.15%)  9
Skin and subcutaneous tissue disorders   
Alopecia * 1  19/33 (57.58%)  22
Dermatology/Skin-Other (Specify,_____) * 1  3/33 (9.09%)  6
Nail changes * 1  2/33 (6.06%)  2
Rash/desquamation * 1  2/33 (6.06%)  2
Vascular disorders   
Edema * 1  6/33 (18.18%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lorna Rodriguez, MD, PhD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: rodriglo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00138151     History of Changes
Other Study ID Numbers: CDR0000433516
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-100101 ( Other Identifier: Cancer Institute of New Jersey )
CINJ-3390 ( Other Identifier: Cancer Institute of New Jersey )
CINJ-NJ1703 ( Other Identifier: Cancer Institute of New Jersey )
First Submitted: August 29, 2005
First Posted: August 30, 2005
Results First Submitted: September 17, 2013
Results First Posted: November 20, 2013
Last Update Posted: November 20, 2013