ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

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: NCT01313884
Recruitment Status : Terminated (Study did not reach primary objective; study did not accrue enough patients.)
First Posted : March 14, 2011
Results First Posted : February 2, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bone Cancer
Ewing's Sarcoma
Interventions Drug: Irinotecan
Drug: Vincristine
Drug: Temozolomide
Drug: Doxorubicin
Drug: Cytoxan
Drug: Pegfilgrastim
Enrollment 3

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Therapy
Hide Arm/Group Description

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Per insurance pvdr, pt can't be on cl tr             1
Arm/Group Title Combination Therapy
Hide Arm/Group Description

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
1
  33.3%
Not Hispanic or Latino
2
  66.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Overall Response Rate (Partial and Complete Response)
Hide Description

Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.

Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.

Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy
Hide Arm/Group Description:

Regimen A alternating with Regimen B every 21 days

Regimen A:

  • Cytoxan 1200mg/m2
  • Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2
  • Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg
  • Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle

Regimen B:

  • Irinotecan 50 mg/m2/day x 5 days
  • Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
2
 100.0%
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data.
Arm/Group Title Combination Therapy
Hide Arm/Group Description:

Regimen A alternating with Regimen B every 21 days

Regimen A:

  • Cytoxan 1200mg/m2
  • Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2
  • Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg
  • Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle

Regimen B:

  • Irinotecan 50 mg/m2/day x 5 days
  • Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported.
Adverse Event Reporting Description Patients were asked about adverse events at every clinic visit.
 
Arm/Group Title Combination Therapy
Hide Arm/Group Description

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Irinotecan: 50 mg/m2/day x 5 days

Vincristine: 2 mg/m2 (capped at 2mg total do)

Temozolomide: 100 mg/m2/day x 5 days

Doxorubicin: 75 mg/m2

Cytoxan: 1200 mg/m2

Pegfilgrastim: 6 mg

Mesna: 240 mg/m2 in 50 ml NS

All-Cause Mortality
Combination Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination Therapy
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/3 (33.33%)  1
Thrombocytopenia  1  1/3 (33.33%)  1
Gastrointestinal disorders   
Diarrhea  1  1/3 (33.33%)  1
General disorders   
Dehydration  1  1/3 (33.33%)  1
Fever  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combination Therapy
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Anemia G2  1  1/3 (33.33%)  2
Worsened anemia G2  1  1/3 (33.33%)  1
Anemia G3  1  1/3 (33.33%)  1
Decreased neutrophils G4  1  1/3 (33.33%)  1
Infection-staph epidermis bacteremia  1  1/3 (33.33%)  1
Platelet count decreased G1  1  1/3 (33.33%)  1
Platelet count decreased G2  1  1/3 (33.33%)  2
Platelet count decreased G4  1  1/3 (33.33%)  1
White blood cells decreased G2  1  1/3 (33.33%)  1
White blood cells decreased G4  1  1/3 (33.33%)  1
Eye disorders   
Disc edema R eye G1  1  1/3 (33.33%)  1
Gastrointestinal disorders   
Decreased energy G1  1  1/3 (33.33%)  1
Fatigue G1  1  1/3 (33.33%)  1
Throat pain G2  1  1/3 (33.33%)  1
Nausea G1  1  1/3 (33.33%)  1
Nausea, intermittent G1  1  1/3 (33.33%)  1
Nausea, intermittent G2  1  1/3 (33.33%)  1
Mucositis oral G1  1  2/3 (66.67%)  2
Oral lesions G1  1  1/3 (33.33%)  1
oral candidiasis G1  1  1/3 (33.33%)  1
Sore throat G1  1  1/3 (33.33%)  1
Pain with swallowing G1  1  1/3 (33.33%)  1
Worsening acid reflux G1  1  1/3 (33.33%)  1
Diarrhea G1  1  2/3 (66.67%)  3
Abdominal cramping G1  1  1/3 (33.33%)  1
Abdominal pain G1  1  1/3 (33.33%)  1
Intermittent diarrhea G1  1  1/3 (33.33%)  1
Vomiting G1  1  1/3 (33.33%)  1
Vomiting intermittent G1  1  1/3 (33.33%)  1
Constipation G1  1  1/3 (33.33%)  1
Nausea and vomiting G1  1  1/3 (33.33%)  1
General disorders   
Intermittent headache G1  1  1/3 (33.33%)  1
Insomnia G1  1  1/3 (33.33%)  1
Insomnia G2  1  1/3 (33.33%)  1
Fever G1  1  1/3 (33.33%)  1
Hiccups G1  1  1/3 (33.33%)  1
Pain generalized 2-3 days post neulasta G1  1  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Hypokalemia G1  1  1/3 (33.33%)  2
Hypocalcemia intermittent G1  1  1/3 (33.33%)  1
Hyponatremia intermittent G1  1  1/3 (33.33%)  1
Intermittent hypoglycemia G1  1  1/3 (33.33%)  1
Hypomagnesemia G1  1  1/3 (33.33%)  1
Hypokalemia G1  1  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Hip pain L G1  1  1/3 (33.33%)  1
Pain sacrum (tailbone) G1  1  1/3 (33.33%)  1
Pain left leg G1  1  1/3 (33.33%)  1
Pain-lowe leg, back G2  1  1/3 (33.33%)  1
Nervous system disorders   
Tingling at left toes G1  1  1/3 (33.33%)  1
Numbness on left shin G1  1  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Cough G1  1  1/3 (33.33%)  1
Nasal congestion G1  1  1/3 (33.33%)  1
Rhinorrhea G1  1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Onychomycosis G2  1  1/3 (33.33%)  1
Hip abscess G3  1  1/3 (33.33%)  1
Erythema L hip G2  1  1/3 (33.33%)  1
Erythema groin crease G1  1  1/3 (33.33%)  1
Erythema left leg G1  1  1/3 (33.33%)  1
Edema left leg pitting 2+, G1  1  1/3 (33.33%)  1
Hyperpigmentation left knee G1  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Study did not reach primary objective; study didn't accrue enough patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kristen Ganjoo, MD
Organization: Stanford University Medical Center
Phone: 650-725-6413
Responsible Party: Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier: NCT01313884     History of Changes
Other Study ID Numbers: IRB-20323
SU-03082011-7559 ( Other Identifier: Stanford University )
SARCOMA0007 ( Other Identifier: OnCore )
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: December 7, 2016
Results First Posted: February 2, 2017
Last Update Posted: November 24, 2017