Trial Outcomes & Findings for Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer (NCT NCT00138151)
NCT ID: NCT00138151
Last Updated: 2013-11-20
Results Overview
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
8 years
Results posted on
2013-11-20
Participant Flow
Subjects were recruited from 4 sites across New Jersey (2 academic medical centers and 2 community hospitals) from March 2001 through June 2009.
Participant milestones
| Measure |
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
* 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 Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
* 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 Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
n=33 Participants
* 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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 12.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 yearsPopulation: Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 yearsPopulation: Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.
Outcome measures
Outcome data not reported
Adverse Events
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
Serious events: 18 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
n=33 participants at risk
* 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
|
|---|---|
|
Investigations
Hyponatremia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
General disorders
Abdominal pain
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Infections and infestations
Infection without neutropenia
|
24.2%
8/33 • Number of events 9 • 8 years
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Blood and lymphatic system disorders
Thrombosis/embolism
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
General disorders
Fever in the absence of neutropenia where neutropenia is defined as AGC <1.0 x 10e9/L
|
12.1%
4/33 • Number of events 4 • 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Renal and urinary disorders
Fistula or GU fistula (e.g., vaginal, vesicovaginal)
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Renal and urinary disorders
Ureteral obstruction
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Vascular disorders
Edema
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Cardiac disorders
Hypertension
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
3/33 • Number of events 6 • 8 years
|
|
Gastrointestinal disorders
Dehydration
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Nervous system disorders
Depressed level of consciousness - somnolence
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Blood and lymphatic system disorders
Vaginal bleeding
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Investigations
Hyperkalemia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
General disorders
Pain (other) - back pain
|
12.1%
4/33 • Number of events 5 • 8 years
|
|
Cardiac disorders
Congestive heart failure
|
3.0%
1/33 • Number of events 2 • 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnea
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Infections and infestations
Infection/Febrile Neutropenia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary other - respiratory failure
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Investigations
Hypocalcemia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Psychiatric disorders
Mood alteration - anxiety, agitation
|
3.0%
1/33 • Number of events 2 • 8 years
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Blood and lymphatic system disorders
Hematuria (in the absence of vaginal bleeding)
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Investigations
Elevated ammonia level
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
General disorders
Death
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Investigations
Hypokalemia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Investigations
Hypomagnesemia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Fracture - neck
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal cord compression
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Renal and urinary disorders
Dysuria
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Nervous system disorders
Change in mental status
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Psychiatric disorders
Hallucinations
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
Blood and lymphatic system disorders
Rectal bleeding/hematochezia
|
3.0%
1/33 • Number of events 1 • 8 years
|
|
General disorders
Rigors/chills
|
3.0%
1/33 • Number of events 1 • 8 years
|
Other adverse events
| Measure |
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
n=33 participants at risk
* 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
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • Number of events 33 • 8 years
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
12/33 • Number of events 15 • 8 years
|
|
Gastrointestinal disorders
Diarrhea, patients without colostomy
|
33.3%
11/33 • Number of events 15 • 8 years
|
|
Gastrointestinal disorders
Constipation
|
30.3%
10/33 • Number of events 13 • 8 years
|
|
Gastrointestinal disorders
Anorexia
|
21.2%
7/33 • Number of events 9 • 8 years
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
18.2%
6/33 • Number of events 6 • 8 years
|
|
Gastrointestinal disorders
Dehydration
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
57.6%
19/33 • Number of events 31 • 8 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
48.5%
16/33 • Number of events 24 • 8 years
|
|
General disorders
Rigors, chills
|
24.2%
8/33 • Number of events 13 • 8 years
|
|
General disorders
Constitutional Symptoms-Other (Specify,_____)
|
12.1%
4/33 • Number of events 6 • 8 years
|
|
General disorders
Pain-Other (Specify,___)
|
51.5%
17/33 • Number of events 31 • 8 years
|
|
General disorders
Headache
|
21.2%
7/33 • Number of events 8 • 8 years
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
18.2%
6/33 • Number of events 6 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
18.2%
6/33 • Number of events 9 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
12.1%
4/33 • Number of events 5 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
3/33 • Number of events 4 • 8 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.6%
19/33 • Number of events 22 • 8 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify,_____)
|
9.1%
3/33 • Number of events 6 • 8 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.3%
9/33 • Number of events 16 • 8 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
27.3%
9/33 • Number of events 33 • 8 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
21.2%
7/33 • Number of events 28 • 8 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify,_____)
|
9.1%
3/33 • Number of events 4 • 8 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Nervous system disorders
Neuropathy-sensory
|
30.3%
10/33 • Number of events 17 • 8 years
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
12.1%
4/33 • Number of events 4 • 8 years
|
|
Psychiatric disorders
Mood alteration-depression
|
12.1%
4/33 • Number of events 4 • 8 years
|
|
Nervous system disorders
Dizziness/lightheadedness
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Nervous system disorders
Insomnia
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Nervous system disorders
Neurology-Other (Specify,______)
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify,____)
|
12.1%
4/33 • Number of events 4 • 8 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
12.1%
4/33 • Number of events 5 • 8 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Renal and urinary disorders
Ureteral obstruction
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Investigations
Hypertriglyceridemia
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Investigations
Hypercholesterolemia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Investigations
Hyperglycemia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Investigations
Hyperuricemia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Investigations
Hypokalemia
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Vascular disorders
Edema
|
18.2%
6/33 • Number of events 7 • 8 years
|
|
Cardiac disorders
Hypertension
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
9.1%
3/33 • Number of events 3 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other (Specify,______)
|
9.1%
3/33 • Number of events 4 • 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
15.2%
5/33 • Number of events 9 • 8 years
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Infections and infestations
Infection without neutropenia
|
6.1%
2/33 • Number of events 3 • 8 years
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Specify,____)
|
6.1%
2/33 • Number of events 3 • 8 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.1%
2/33 • Number of events 2 • 8 years
|
|
Endocrine disorders
Hot flashes/flushes
|
9.1%
3/33 • Number of events 3 • 8 years
|
Additional Information
Lorna Rodriguez, MD, PhD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place