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Trial record 29 of 42 for:    Malignant Hyperthermia 5

Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal 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: NCT02010567
Recruitment Status : Active, not recruiting
First Posted : December 12, 2013
Results First Posted : November 14, 2017
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Cerulean Pharma Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rectal Cancer
Interventions Drug: CRLX101
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery
Enrollment 32
Recruitment Details Patients were recruited from 5 medical institutions between December 2013 and September 2016
Pre-assignment Details A total of 39 patients were consented to this study; 4 patients were found ineligible, 3 withdrew prior to treatment, leaving 32 patients who went on study.
Arm/Group Title Cohort A, Phase Ib, Dose Level 1 Cohort A, Phase Ib, Dose Level 2 Cohort A, Phase II, Dose Level 2 Cohort B, Phase Ib, Dose Level 1, Weekly Cohort B, Phase Ib, Dose Level 2, Weekly
Hide Arm/Group Description

CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

Period Title: Overall Study
Started 3 6 14 3 6
Completed 3 6 13 3 5
Not Completed 0 0 1 0 1
Reason Not Completed
Adverse Event             0             0             1             0             1
Arm/Group Title Cohort A, Phase Ib, Dose Level 1 Cohort A, Phase Ib, Dose Level 2 Cohort A, Phase II, Dose Level 2 Cohort B, Phase Ib, Dose Level 1, Weekly Cohort B, Phase Ib, Dose Level 2, Weekly Total
Hide Arm/Group Description

CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 by mouth two times a day (PO BID), Monday through Friday (M-F) XRT 180 centigray (cGy)/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 12mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

CRLX101 15mg/ m^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.

Capecitabine 825mg/ m^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 3 6 14 3 6 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 14 participants 3 participants 6 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
4
  66.7%
14
 100.0%
3
 100.0%
5
  83.3%
28
  87.5%
>=65 years
1
  33.3%
2
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
4
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 14 participants 3 participants 6 participants 32 participants
Female
2
  66.7%
1
  16.7%
4
  28.6%
0
   0.0%
3
  50.0%
10
  31.3%
Male
1
  33.3%
5
  83.3%
10
  71.4%
3
 100.0%
3
  50.0%
22
  68.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 14 participants 3 participants 6 participants 32 participants
American Indian or Alaska Native 0 0 0 0 0 0
Asian 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 0 1 3 0 1 5
White 3 5 11 3 4 26
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 1 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 6 participants 14 participants 3 participants 6 participants 32 participants
3
 100.0%
6
 100.0%
14
 100.0%
3
 100.0%
6
 100.0%
32
 100.0%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer
Hide Description The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) >3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting >48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in <50% of the scheduled capecitabine dose for entire course
Time Frame 12 weeks
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Hide Analysis Population Description
Since this objective applies only to Phase Ib patients, the Phase II cohort patients were not included
Arm/Group Title Dose Escalation Phase Ib
Hide Arm/Group Description:
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: mg/m^2 every other week
15
2.Primary Outcome
Title Pathological Complete Response (pCR) Rate
Hide Description Primary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.
Time Frame 12 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with pCR
19
(7 to 36)
3.Secondary Outcome
Title Pathological Response Rate
Hide Description

Pathologic response will be made based on microscopic assessment of the surgical specimen at the primary treatment site, including regional nodes and any peritumoral satellite nodules in the specimen, and categorized as outlined below as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 7th edition.Determination of pathological response will be reported by the local pathologist.

  • Pathologic Complete Response (pCR): No gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.
  • Moderate response: Single cells or small groups of cancer cells
  • Minimal response: Residual cancer outgrown by fibrosis
  • Poor response:Minimal or no tumor kill; extensive residual cancer
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
pCR
6
  18.8%
Moderate response
18
  56.3%
Minimal response
7
  21.9%
Unknown
1
   3.1%
4.Secondary Outcome
Title Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Hide Description Toxicity profile of CRLX101 when combined with capecitabine + radiotherapy to treat patients with locally advanced rectal cancer. Phase Ib and Phase II - Safety is the reported adverse event (AE) profile characterized by NCI CTCAE v4.0. The profile was limited to grade 3 or higher, treatment related AEs.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
All resectable participants who received CRLX101 + capecitabine (Cape) and radiation therapy (XRT) regardless of dose and timing of treatment
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants with AE
Colitis 1
Dermatitis, radiation 1
Diarrhea 1
Hypophosphatemia 1
Lymphocyte count decreased 9
Rectal obstruction 1
White blood cell decreased 1
5.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.
Time Frame 6 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Phase II only - OS is defined as the time from surgical resection until death
Time Frame 6 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Disease-free Survival (DFS) and Overall Survival (OS) Based on Pathological Complete Response (pCR).
Hide Description Phase II only - a comparison of DFS and OS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.OS is defined as the time from surgical resection until death
Time Frame 6 years
Outcome Measure Data Not Reported
Time Frame Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
Adverse Event Reporting Description All patients were evaluated for serious adverse events (SAEs)
 
Arm/Group Title Cohort A, Phase Ib, Level 1 Cohort A, Phase Ib, Level 2 Cohort A, Phase II, Level 2 Cohort B, Phase Ib, Level 1 Cohort B, Phase Ib, Level 2
Hide Arm/Group Description 12mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT 15mg/m^2 CRLX101 every other week + 825mg/m^2 BID Capecitabine + XRT 15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT 12mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT 15mg/m^2 CRLX101 IV weekly + 825mg/m^2 BID Capecitabine + XRT
All-Cause Mortality
Cohort A, Phase Ib, Level 1 Cohort A, Phase Ib, Level 2 Cohort A, Phase II, Level 2 Cohort B, Phase Ib, Level 1 Cohort B, Phase Ib, Level 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/6 (0.00%)      0/14 (0.00%)      0/3 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A, Phase Ib, Level 1 Cohort A, Phase Ib, Level 2 Cohort A, Phase II, Level 2 Cohort B, Phase Ib, Level 1 Cohort B, Phase Ib, Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/6 (0.00%)      1/14 (7.14%)      0/3 (0.00%)      0/6 (0.00%)    
Gastrointestinal disorders           
Colonic obstruction * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A, Phase Ib, Level 1 Cohort A, Phase Ib, Level 2 Cohort A, Phase II, Level 2 Cohort B, Phase Ib, Level 1 Cohort B, Phase Ib, Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      6/6 (100.00%)      14/14 (100.00%)      3/3 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders           
Anemia * 1  1/3 (33.33%)  1 4/6 (66.67%)  4 11/14 (78.57%)  11 2/3 (66.67%)  2 4/6 (66.67%)  4
Thrombotic thrombocytopenic purpura * 1  0/3 (0.00%)  0 2/6 (33.33%)  2 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders           
Atrial fibrillation * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Ventricular arrhythmia * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Ear and labyrinth disorders           
Ear pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Hearing impaired * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain * 1  0/3 (0.00%)  0 4/6 (66.67%)  4 2/14 (14.29%)  2 0/3 (0.00%)  0 3/6 (50.00%)  3
Anal hemorrhage * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Anal pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Bloating * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Colitis * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Constipation * 1  1/3 (33.33%)  1 4/6 (66.67%)  4 4/14 (28.57%)  4 3/3 (100.00%)  3 1/6 (16.67%)  1
Diarrhea * 1  2/3 (66.67%)  2 4/6 (66.67%)  4 10/14 (71.43%)  10 0/3 (0.00%)  0 5/6 (83.33%)  5
Flatulence * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastroesophageal reflux disease * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Hemorrhoids * 1  1/3 (33.33%)  1 1/6 (16.67%)  1 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Ileus * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Mucositis oral * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Nausea * 1  3/3 (100.00%)  3 3/6 (50.00%)  3 5/14 (35.71%)  5 1/3 (33.33%)  1 2/6 (33.33%)  2
Rectal hemorrhage * 1  1/3 (33.33%)  1 2/6 (33.33%)  2 5/14 (35.71%)  5 1/3 (33.33%)  1 1/6 (16.67%)  1
Rectal mucositis * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rectal obstruction * 1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rectal pain * 1  3/3 (100.00%)  3 3/6 (50.00%)  3 4/14 (28.57%)  4 3/3 (100.00%)  3 3/6 (50.00%)  3
Vomiting * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1
General disorders           
Chills * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Edema limbs * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Fatigue * 1  2/3 (66.67%)  2 3/6 (50.00%)  3 11/14 (78.57%)  11 2/3 (66.67%)  2 5/6 (83.33%)  5
Fever * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Infusion related reaction * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Non-cardiac chest pain * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/14 (14.29%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations           
Upper respiratory infection * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Vaginal infection * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Injury, poisoning and procedural complications           
Dermatitis radiation * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Investigations           
Alanine aminotransferase increased * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1
Alkaline phosphatase increased * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Aspartate aminotransferase increased * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Blood bilirubin increased * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Cholesterol high * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Creatinine increased * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Lymphocyte count decreased * 1  3/3 (100.00%)  3 3/6 (50.00%)  3 8/14 (57.14%)  8 2/3 (66.67%)  2 4/6 (66.67%)  4
Neutrophil count decreased * 1  2/3 (66.67%)  2 0/6 (0.00%)  0 2/14 (14.29%)  2 2/3 (66.67%)  2 3/6 (50.00%)  3
Platelet count decreased * 1  0/3 (0.00%)  0 3/6 (50.00%)  3 3/14 (21.43%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0
Weight loss * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
White blood cell decreased * 1  3/3 (100.00%)  3 2/6 (33.33%)  2 5/14 (35.71%)  5 2/3 (66.67%)  2 3/6 (50.00%)  3
Metabolism and nutrition disorders           
Anorexia * 1  1/3 (33.33%)  1 1/6 (16.67%)  1 4/14 (28.57%)  4 1/3 (33.33%)  1 2/6 (33.33%)  2
Dehydration * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Hyperglycemia * 1  0/3 (0.00%)  0 4/6 (66.67%)  4 5/14 (35.71%)  5 0/3 (0.00%)  0 1/6 (16.67%)  1
Hyperkalemia * 1  0/3 (0.00%)  0 2/6 (33.33%)  2 1/14 (7.14%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2
Hypermagnesemia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 5/14 (35.71%)  5 0/3 (0.00%)  0 2/6 (33.33%)  2
Hypertriglyceridemia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypoalbuminemia * 1  0/3 (0.00%)  0 2/6 (33.33%)  2 3/14 (21.43%)  3 2/3 (66.67%)  2 0/6 (0.00%)  0
Hypocalcemia * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 3/14 (21.43%)  3 3/3 (100.00%)  3 0/6 (0.00%)  0
Hypoglycemia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypokalemia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Hypomagnesemia * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/14 (14.29%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0
Hyponatremia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/14 (14.29%)  2 2/3 (66.67%)  2 4/6 (66.67%)  4
Hypophosphatemia * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 4/14 (28.57%)  4 3/3 (100.00%)  3 3/6 (50.00%)  3
Musculoskeletal and connective tissue disorders           
Back pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 3/14 (21.43%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0
Generalized muscle weakness * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Muscle weakness lower limb * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Pain in extremity * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders           
Dizziness * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Headache * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Memory impairment * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Peripheral sensory neuropathy * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Somnolence * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders           
Anxiety * 1  0/3 (0.00%)  0 2/6 (33.33%)  2 2/14 (14.29%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0
Depression * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Insomnia * 1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders           
Bladder spasm * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Cystitis noninfective * 1  0/3 (0.00%)  0 2/6 (33.33%)  2 4/14 (28.57%)  4 1/3 (33.33%)  1 2/6 (33.33%)  2
Hematuria * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2
Proteinuria * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders - Other, specify * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Urinary frequency * 1  1/3 (33.33%)  1 2/6 (33.33%)  2 5/14 (35.71%)  5 2/3 (66.67%)  2 2/6 (33.33%)  2
Urinary tract pain * 1  3/3 (100.00%)  3 1/6 (16.67%)  1 1/14 (7.14%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Urinary urgency * 1  1/3 (33.33%)  1 1/6 (16.67%)  1 2/14 (14.29%)  2 1/3 (33.33%)  1 1/6 (16.67%)  1
Reproductive system and breast disorders           
Perineal pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Vaginal pain * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders           
Hiccups * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Nasal congestion * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Productive cough * 1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Sleep apnea * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Sore throat * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders           
Dry skin * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2
Pain of skin * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2
Palmar-plantar erythrodysesthesia syndrome * 1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rash acneiform * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Rash maculo-papular * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders - Other, specify * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Skin hyperpigmentation * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders           
Hypertension * 1  0/3 (0.00%)  0 3/6 (50.00%)  3 4/14 (28.57%)  4 1/3 (33.33%)  1 1/6 (16.67%)  1
Phlebitis * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Thromboembolic event * 1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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: Robin Johnson
Organization: UNC Lineberger
Phone: 919-966-1125
EMail: robin_v_johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02010567     History of Changes
Other Study ID Numbers: LCCC 1315
First Submitted: December 9, 2013
First Posted: December 12, 2013
Results First Submitted: October 13, 2017
Results First Posted: November 14, 2017
Last Update Posted: January 8, 2019