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Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical 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: NCT00071058
Recruitment Status : Completed
First Posted : October 10, 2003
Results First Posted : September 12, 2012
Last Update Posted : September 18, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adrenal Cortex Neoplasms
Intervention Drug: XR9576 (Tariquidar)
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery Plus Chemotherapy
Hide Arm/Group Description

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

Period Title: Overall Study
Started 50
Completed 49
Not Completed 1
Reason Not Completed
brain tumor-removed from study             1
Arm/Group Title Surgery Plus Chemothrapy
Hide Arm/Group Description

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
49
  98.0%
>=65 years
1
   2.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
45.56  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
37
  74.0%
Male
13
  26.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
1
   2.0%
Not Hispanic or Latino
48
  96.0%
Unknown or Not Reported
1
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.0%
White
46
  92.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Percentage of Participants With a Partial or Complete Response
Hide Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.
Time Frame Every 6 weeks for up to a year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery Plus Chemotherapy
Hide Arm/Group Description:

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response 4
Partial Response 6
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 60 months, 19 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery Plus Chemotherapy
Hide Arm/Group Description:

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Participants
49
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Surgery Plus Chemothrapy
Hide Arm/Group Description

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

All-Cause Mortality
Surgery Plus Chemothrapy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Surgery Plus Chemothrapy
Affected / at Risk (%) # Events
Total   13/50 (26.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC)  1  1/50 (2.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  3/50 (6.00%)  3
Cardiac disorders   
Cardiac left ventricular function  1  1/50 (2.00%)  1
Cardiac-ischemia/infarction  1  1/50 (2.00%)  2
Thrombosis/embolism  1  2/50 (4.00%)  2
Gastrointestinal disorders   
Anorexia  1  1/50 (2.00%)  1
Constipation  1  3/50 (6.00%)  3
Dehydration  1  1/50 (2.00%)  1
Diarrhea patients without colostomy  1  1/50 (2.00%)  1
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  1/50 (2.00%)  1
Ileus (or neuroconstipation)  1  1/50 (2.00%)  1
Nausea  1  5/50 (10.00%)  5
Vomiting  1  3/50 (6.00%)  3
Abdominal pain or cramping  1  2/50 (4.00%)  2
General disorders   
Fatigue (lethargy, malaise, asthenia)  1  1/50 (2.00%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  5/50 (10.00%)  5
Rigors/chills  1  1/50 (2.00%)  1
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/50 (2.00%)  1
Infections and infestations   
Febrile Neutropenia  1 [1]  2/50 (4.00%)  2
Infection  1 [2]  1/50 (2.00%)  1
Infection without neutropenia  1  1/50 (2.00%)  1
Metabolism and nutrition disorders   
Hyponatremia  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/50 (2.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[2]
(documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery Plus Chemothrapy
Affected / at Risk (%) # Events
Total   49/50 (98.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  47/50 (94.00%)  176
Leukocytes (total WBC)  1  34/50 (68.00%)  62
Neutrophils/granulocytes (ANC/AGC)  1  45/50 (90.00%)  101
Platelets  1  33/50 (66.00%)  109
Prothrombin time (PT)  1  1/50 (2.00%)  1
Hematuria (in the absence of vaginal bleeding)  1  2/50 (4.00%)  2
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  1/50 (2.00%)  1
Vaginal bleeding  1  2/50 (4.00%)  2
Cardiac disorders   
Palpitations  1  1/50 (2.00%)  1
Sinus tachycardia  1  1/50 (2.00%)  1
Vasovagal episode  1  1/50 (2.00%)  1
Cardiac left ventricular function  1  1/50 (2.00%)  1
Edema  1  6/50 (12.00%)  6
Hypertension  1  1/50 (2.00%)  1
Hypotension  1  1/50 (2.00%)  1
Peripheral arterial ischemia  1  1/50 (2.00%)  1
Thrombosis/embolism  1  4/50 (8.00%)  4
Ear and labyrinth disorders   
Earache (otalgia)  1  1/50 (2.00%)  1
Endocrine disorders   
Hot flashes/flushes  1  4/50 (8.00%)  6
Eye disorders   
Cataract  1  1/50 (2.00%)  1
Conjunctivitis  1  1/50 (2.00%)  1
Dry eye  1  1/50 (2.00%)  1
Tearing (watery eyes)  1  2/50 (4.00%)  2
Vision-blurred vision  1  4/50 (8.00%)  4
Vision-flashing lights/floaters  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Anorexia  1  33/50 (66.00%)  56
Constipation  1  28/50 (56.00%)  45
Dehydration  1  6/50 (12.00%)  8
Diarrhea patients without colostomy  1  28/50 (56.00%)  56
Dyspepsia/heartburn  1  8/50 (16.00%)  9
Dysphagia, esophagitis, odynophagia (painful swallowing)  1  4/50 (8.00%)  7
Flatulence  1  3/50 (6.00%)  3
Ileus (or neuroconstipation)  1  1/50 (2.00%)  1
Nausea  1  42/50 (84.00%)  91
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  30/50 (60.00%)  61
Taste disturbance (dysgeusia)  1  10/50 (20.00%)  16
Vomiting  1  30/50 (60.00%)  54
Abdominal pain or cramping  1  19/50 (38.00%)  29
Rectal or perirectal pain (proctalgia)  1  1/50 (2.00%)  1
Gastrointestinal-Other (Specify, dental extraction; early satiety; bloating)  1  3/50 (6.00%)  3
General disorders   
Fatigue (lethargy, malaise, asthenia)  1  44/50 (88.00%)  111
Fever  1 [1]  12/50 (24.00%)  13
Rigors, chills  1  1/50 (2.00%)  1
Sweating (diaphoresis)  1  3/50 (6.00%)  4
Weight loss  1  11/50 (22.00%)  15
Chest pain (non-cardiac and non-pleuritic)  1  2/50 (4.00%)  2
Pain-Other (Specify, Back Pain; Neck; Flank R; Pain in right rib )  1  4/50 (8.00%)  4
Hepatobiliary disorders   
Alkaline phosphatase  1  13/50 (26.00%)  22
Bilirubin  1  4/50 (8.00%)  4
Hypoalbuminemia  1  25/50 (50.00%)  55
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  26/50 (52.00%)  58
SGPT (ALT) (serum glutamic pyruvic transaminase)  1  23/50 (46.00%)  52
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  3/50 (6.00%)  3
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  9/50 (18.00%)  11
Infections and infestations   
Catheter-related infection  1  1/50 (2.00%)  1
Febrile neutropenia  1 [2]  3/50 (6.00%)  3
Infection  1 [3]  2/50 (4.00%)  2
Infection without neutropenia  1  16/50 (32.00%)  29
Infection/Febrile Neutropenia-Other (Specify, vag. yeast infection)  1 [4]  3/50 (6.00%)  4
Metabolism and nutrition disorders   
Hypercalcemia  1  1/50 (2.00%)  3
Hyperglycemia  1  1/50 (2.00%)  1
Hyperkalemia  1  1/50 (2.00%)  1
Hypermagnesemia  1  1/50 (2.00%)  1
Hypernatremia  1  1/50 (2.00%)  2
Hypocalcemia  1  5/50 (10.00%)  5
Hypokalemia  1  23/50 (46.00%)  44
Hypomagnesemia  1  9/50 (18.00%)  15
Hyponatremia  1  17/50 (34.00%)  22
Musculoskeletal and connective tissue disorders   
Muscle weakness (not due to neuropathy)  1  9/50 (18.00%)  10
Musculoskeletal-Other (Specify, fracture of L. fibula)  1  1/50 (2.00%)  1
Arthralgia (joint pain)  1  33/50 (66.00%)  93
Bone pain  1  2/50 (4.00%)  3
Myalgia (muscle pain)  1  11/50 (22.00%)  18
Nervous system disorders   
Ataxia (incoordination)  1  4/50 (8.00%)  4
Confusion  1  5/50 (10.00%)  5
Dizziness/lightheadedness  1  7/50 (14.00%)  9
Insomnia  1  6/50 (12.00%)  8
Mood alteration-anxiety, agitation  1  2/50 (4.00%)  2
Mood alteration-depression  1  3/50 (6.00%)  5
Neurology-Other (Specify, largyngitis, voice hoarseness; neurology: Tinnitus L>R )  1  2/50 (4.00%)  2
Neuropathy - motor  1  2/50 (4.00%)  2
Neuropathy-sensory  1  29/50 (58.00%)  48
Headache  1  9/50 (18.00%)  12
Renal and urinary disorders   
Proteinuria  1  1/50 (2.00%)  1
Urinary frequency/urgency  1  3/50 (6.00%)  4
Urinary retention  1  5/50 (10.00%)  5
Reproductive system and breast disorders   
Vaginitis (not due to infection)  1  1/50 (2.00%)  1
Sexual/Reproductive Function-Other (Specify, Amenorrhea)  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pleuritic pain  1  1/50 (2.00%)  1
Cough  1  3/50 (6.00%)  3
Dyspnea (shortness of breath)  1  12/50 (24.00%)  14
Hypoxia  1  1/50 (2.00%)  1
Pneumothorax  1  1/50 (2.00%)  1
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  3/50 (6.00%)  4
Skin and subcutaneous tissue disorders   
Alopecia  1  34/50 (68.00%)  37
Bruising (in absence of grade 3 or 4 thrombocytopenia)  1  2/50 (4.00%)  2
Hand-foot skin reaction  1  3/50 (6.00%)  6
Nail changes  1  1/50 (2.00%)  1
Pigmentation changes (e.g., vitiligo)  1  1/50 (2.00%)  1
Rash/desquamation  1  8/50 (16.00%)  9
Dermatology/Skin-Other (Specify, Head Rash; pain: port problems, pain, redness )  1  2/50 (4.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
(in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[2]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[3]
(documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
[4]
"Thrush", zoster, herpes L butt
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Antonio Fojo, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-2631
EMail: FojoT@mail.nih.gov
Layout table for additonal information
Responsible Party: Antonio Fojo, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00071058    
Obsolete Identifiers: NCT00073996
Other Study ID Numbers: 040011
04-C-0011
First Submitted: October 9, 2003
First Posted: October 10, 2003
Results First Submitted: August 13, 2012
Results First Posted: September 12, 2012
Last Update Posted: September 18, 2012