Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00644189
• Collaborator: Dana-Farber Cancer Institute (Other), Brigham and Women's Hospital (Other), Genzyme, a Sanofi Company (Industry)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 169
• Patients Per Site: 25
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell.

This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Low Grade B-cell Lymphoma, Not Otherwise Specified; Diffuse Large B-cell Lymphoma; Peripheral T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large-cell Lymphoma	Drug: Clofarabine	Phase 1/Phase 2

Detailed Description

• Each treatment cycle lasts four weeks during which time the participant will be taking study drug for the first three weeks only. Participants will be supplied with a study medication-dosing calendar for each treatment cycle.

• Clofarabine is a tablet that will be taken orally in the morning once daily on days 1 through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if they do not experience any unacceptable side effects and if their cancer does not get worse.

• The following tests and procedures will be performed at specified intervals through out the treatment period: blood tests, physical examinations, vital signs, radiological exams and urine tests.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Clofarabine Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.	Drug: Clofarabine; Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.; Other Names: Clolar

Outcome Measures

Primary Outcome Measures

1. All Phase I-II Participants: Overall Response Rate (ORR) [after at most 6 28-day cycles]

   Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

2. Phase I Participants Only: Overall Response Rate (ORR) [after at most 6 28-day cycles]

   Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

1. Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) [after at most 6 28-day cycles]

   To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

2. All Phase I-II Participants: Progression-free Survival (PFS) [at 1 and 2 years]

   Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

3. All Phase I-II Participants: Overall Survival (OS) [3 years]

   Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

4. All Phase I-II Participants: Safety [during 6 28-day cycles and 90 days out]

   Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

5. Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR) [after at most 6 28-day cycles]

   To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

6. Phase I Participants: Progression-free Survival (PFS) [at 17 months]

   Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

7. All Phase I Participants: Overall Survival (OS) [at 17 months]

   Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

8. Phase I Participants: Safety [during 6 28-day cycles and 90 days out]

   Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.

• One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.

• Measurable disease on cross sectional imaging of at least 2cm.

• ECOG Performance Status 0-2

• 18 years of age or older

• Life expectancy of greater than 3 months

• Normal organ and marrow function as outlined in the protocol

• Must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

• Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study

• Receiving any other investigational agent

• Known brain metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine

• Systemic fungal, bacterial, viral, or other infection not controlled

• Pregnant or lactating

• Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Prior allogeneic stem cell transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Massachusetts General Hospital
• Dana-Farber Cancer Institute
• Brigham and Women's Hospital
• Genzyme, a Sanofi Company

Investigators

• Principal Investigator: Jeremy Abramson, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00644189
• Other Study ID Numbers: 07-401
• First Posted: Mar 26, 2008
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital: clofarabine; Clolar; lymphoma; NHL; oral chemotherapy
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Anaplastic; Waldenstrom Macroglobulinemia; Immunoblastic Lymphadenopathy; Clofarabine

Study Results

Participant Flow

Arm/Group Title	Clofarabine 1 mg	Clofarabine 2 mg	Clofarabine 4 mg	Clofarabine: 3 mg
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Period Title: Phase I
STARTED	3	3	6	18
COMPLETED	3	3	6	18
NOT COMPLETED	0	0	0	0
Period Title: Phase I
STARTED	0	0	0	50
Completed All 6 Cycles of Treatment	0	0	0	19
COMPLETED	0	0	0	50
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Clofarabine Phase I
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Overall Participants	30
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	15 50%
Male	15 50%
Region of Enrollment (participants) [Number]
United States	30 100%
Number of prior regimens (number of prior regimens) [Median (Full Range) ]
Median (Full Range) [number of prior regimens]	1
Histologies (Count of Participants)
follicular lymphoma (FL)	7 23.3%
small lymphocytic lymphoma (SLL)	6 20%
diffuse large B-cell lymphoma (DLBCL)	3 10%
marginal zone lymphoma (MZL)	7 23.3%
mantle cell lymphoma (MCL)	6 20%
T-cell lymphoma (TCL)	0 0%
lymphoplasmacytic lymphoma (LPL)	1 3.3%

Outcome Measures

1. Primary Outcome

Title	All Phase I-II Participants: Overall Response Rate (ORR)
Description	Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	after at most 6 28-day cycles

Outcome Measure Data

Analysis Population Description

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

Arm/Group Title	Phase I-II
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	28 93.3%

2. Primary Outcome

Title	Phase I Participants Only: Overall Response Rate (ORR)
Description	Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	after at most 6 28-day cycles

Outcome Measure Data

Analysis Population Description

Phase I participants only

Arm/Group Title	Phase I
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	30
Mean (90% Confidence Interval) [percentage of participants]	47 156.7%

3. Secondary Outcome

Title	Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
Description	To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	after at most 6 28-day cycles

Outcome Measure Data

Analysis Population Description

only participants from phase I-II trial who were treated at the RP2D (3mg)

Arm/Group Title	Clofarabine
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	36
Number (95% Confidence Interval) [percentage of participants]	28 93.3%

4. Secondary Outcome

Title	All Phase I-II Participants: Progression-free Survival (PFS)
Description	Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	at 1 and 2 years

Outcome Measure Data

Analysis Population Description

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

Arm/Group Title	Clofarabine
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	50
1-year PFS	32
2-year PFS	16

5. Secondary Outcome

Title	All Phase I-II Participants: Overall Survival (OS)
Description	Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

Arm/Group Title	Clofarabine
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	58 193.3%

6. Secondary Outcome

Title	All Phase I-II Participants: Safety
Description	Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
Time Frame	during 6 28-day cycles and 90 days out

Outcome Measure Data

Analysis Population Description

all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine

Arm/Group Title	Clofarabine
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	50
Any grade 3-4 toxicity	29 96.7%
Leukopenia and neutropenia	24 80%
Thrombocytopenia	15 50%
Anemia	7 23.3%
Fatigue	3 10%

7. Secondary Outcome

Title	Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
Description	To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	after at most 6 28-day cycles

Outcome Measure Data

Analysis Population Description

Phase I participants only who were treated at the RP2D (3mg)

Arm/Group Title	Phase I
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	16
Complete Response (CR)	5 16.7%
Partial Response (PR)	4 13.3%
Stable Disease (SD) or Progressive Disease (PD)	7 23.3%

8. Secondary Outcome

Title	Phase I Participants: Progression-free Survival (PFS)
Description	Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	at 17 months

Outcome Measure Data

Analysis Population Description

Phase I participants only

Arm/Group Title	Phase I
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	30
Mean (90% Confidence Interval) [percentage of participants]	34 113.3%

9. Secondary Outcome

Title	All Phase I Participants: Overall Survival (OS)
Description	Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
Time Frame	at 17 months

Outcome Measure Data

Analysis Population Description

Phase I participants only

Arm/Group Title	Phase I
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	30
Mean (90% Confidence Interval) [percentage of participants]	75 250%

10. Secondary Outcome

Title	Phase I Participants: Safety
Description	Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
Time Frame	during 6 28-day cycles and 90 days out

Outcome Measure Data

Analysis Population Description

Phase I participants only

Arm/Group Title	Phase I
Arm/Group Description	Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Measure Participants	30
Anemia	19 63.3%
Neutropenia	18 60%
Thrombocytopenia	9 30%
Fatigue	8 26.7%
Neutropenic fever	1 3.3%
Grade 3-4 infections	3 10%
Any grade 3-4 toxicity	20 66.7%

Adverse Events

Arm/Group Title	Clofarabine
Arm/Group Description	Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
All Cause Mortality
	Clofarabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Clofarabine
	Affected / at Risk (%)	# Events
Total	15/50 (30%)
Blood and lymphatic system disorders
Anemia	5/50 (10%)	6
Death (due to disease Progression)	2/50 (4%)	2
Febrile Neutropenia	2/50 (4%)	2
Leukopenia	1/50 (2%)	2
Neutropenia	3/50 (6%)	5
Petechia	1/50 (2%)	1
Thrombocytopenia	5/50 (10%)	7
Cardiac disorders
Pericarditis	1/50 (2%)	1
Gastrointestinal disorders
Constipation	1/50 (2%)	1
Diarrhea	2/50 (4%)	3
suspected GI Bleed	1/50 (2%)	1
General disorders
Fatigue	1/50 (2%)	1
Fever	1/50 (2%)	1
Pain - Left Flank	1/50 (2%)	1
Infections and infestations
Infection	2/50 (4%)	2
Suspected respiratory tract infection	1/50 (2%)	1
Metabolism and nutrition disorders
Hypercalcemia	1/50 (2%)	1
Musculoskeletal and connective tissue disorders
Weakness in legs	1/50 (2%)	1
Nervous system disorders
CNS Cerebrovascular Ischemia	1/50 (2%)	1
CNS Hemorrhage	1/50 (2%)	1
Renal and urinary disorders
Kidney Failure	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	3/50 (6%)	3
Pneumonia	1/50 (2%)	1
Vascular disorders
Hypotension	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Clofarabine
	Affected / at Risk (%)	# Events
Total	50/50 (100%)
Blood and lymphatic system disorders
Platelets	50/50 (100%)	253
Febrile neutropenia	50/50 (100%)	253
Thrombotic thrombocytopenic purpura	50/50 (100%)	253
Leukocytosis	50/50 (100%)	252
Edema limb	5/50 (10%)	14
Lymphopenia	4/50 (8%)	13
Cardiac disorders
Cardiac-other	3/50 (6%)	4
Gastrointestinal disorders
Ascites	50/50 (100%)	254
Nausea	50/50 (100%)	252
Vomiting	50/50 (100%)	252
Constipation	11/50 (22%)	15
Dyspepsia	6/50 (12%)	9
Gastrointestinal disorders - Other, specify	4/50 (8%)	9
Anorexia	4/50 (8%)	7
General disorders
Chills	50/50 (100%)	255
Head/headache	50/50 (100%)	252
Back, pain	7/50 (14%)	12
Joint, pain	7/50 (14%)	10
Abdomen, pain	7/50 (14%)	9
Insomnia	4/50 (8%)	8
Fatigue	4/50 (8%)	5
Pelvic, pain	3/50 (6%)	6
Fever w/o neutropenia	3/50 (6%)	4
Weight loss	3/50 (6%)	3
Pain-other	3/50 (6%)	3
Immune system disorders
Allergic rhinitis	5/50 (10%)	9
Infections and infestations
Infection Gr0-2 neut, upper airway	4/50 (8%)	7
Infection Gr0-2 neut, skin	3/50 (6%)	5
Metabolism and nutrition disorders
Hypokalemia	10/50 (20%)	32
AST, SGOT	10/50 (20%)	17
Dehydration	8/50 (16%)	14
Hyperkalemia	8/50 (16%)	14
Alkaline phosphatase	5/50 (10%)	16
Hypophosphatemia	5/50 (10%)	11
Hypernatremia	5/50 (10%)	6
Hyponatremia	5/50 (10%)	6
Hypoalbuminemia	4/50 (8%)	6
Hypoalbuminemia	3/50 (6%)	3
Musculoskeletal and connective tissue disorders
Arthritis	3/50 (6%)	7
Nervous system disorders
Brachial plexopathy	11/50 (22%)	16
Movements involuntary	7/50 (14%)	17
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	12/50 (24%)	27
Bronchial stricture	11/50 (22%)	24
Pulmonary/Upper Respiratory-other	4/50 (8%)	6
Skin and subcutaneous tissue disorders
Rash/desquamation	50/50 (100%)	244
Chemoradiation dermatitis	7/50 (14%)	7
Pruritus/itching	5/50 (10%)	9
Skin and subcutaneous tissue disorders - Other, specify	3/50 (6%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.