Sutent + Taxol for Advanced Esophageal Cancer

• Sponsor: Hoosier Cancer Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00730353
• Collaborator: Pfizer (Industry)
• Enrollment: 28
• Locations: 15
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Sunitinib malate; Drug: Paclitaxel	Phase 2

Detailed Description

OUTLINE: This is a multi-center study.

Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.

• Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

• Sunitinib malate 37.5 mg orally, daily.

After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.

Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2

Life expectancy: Not specified

Hematopoietic:

• International Normalized Ratio (INR) < 1.2

• Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN)

• Platelets > 100 K/mm3

• Hemoglobin > 8 g/dL

• Absolute Neutrophil Count (ANC) > 1.0 K/mm3

Hepatic:

• Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.

• Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.

• Total bilirubin < 2.0 x ULN

Renal:

• Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) > 50 cc/min

Cardiovascular:

• No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months.

• No history of New York Heart Association class II or greater congestive heart failure.

Pulmonary:

• Not specified

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1 Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.

Drug: Sunitinib malate; Sunitinib malate 37.5 mg orally, daily; Drug: Paclitaxel; Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival Rate at 24 Weeks [24 weeks]

   To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Secondary Outcome Measures

1. Response Rate [6 months]

   To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

2. Overall Survival [12 months]

   To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma

3. Progression-Free Survival [12 months]

   To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

4. Toxicity Profile [16 months]

   Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma

• Measurable or evaluable disease per RECIST within 28 days prior to being registered on protocol therapy.

• No more than one prior chemotherapy regimen for locally advanced or metastatic disease is allowed.

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

• Age > 18 years.

• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for 3 month period thereafter.

• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

• Females must not be breastfeeding.

• Must be willing to comply with study and follow up procedures.

Exclusion Criteria:

• No history of inadequately controlled hypertension (Systolic Blood Pressure > 150 or Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.

• No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor (EGFR) inhibitor, or other anti-angiogenic agent.

No serious, non-healing wound, ulcer, or bone fracture.

• No history of or current hemoptysis.

• No history of transient ischemic attack (TIA) or stroke within 12 months prior to registration for protocol therapy.

• No evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT.

• No chronic anti-coagulation treatment.

• No history of central nervous system or brain metastases.

• No history of any major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy, or anticipation of need for major surgical procedure during the course of protocol therapy.

• No history of any minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.

• No history of clinically significant peripheral neuropathy, i.e., Grade > 3 neuromotor or neurosensory toxicity as defined by NCI CTCAE v 3.0.

• No known history of adrenal insufficiency documented by adrenocorticotropic hormone (ACTH) stimulation testing.

• No prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec), obtained within 28 days prior to being registered for protocol therapy.

• No other active cancers

• No clinically significant infections as judged by the treating investigator.

• No history of a seizure disorder.

• No known history of hypersensitivity to paclitaxel.

• No CYP3A4 inducers and inhibitors allowed within 14 days prior to registration on protocol therapy and while receiving the protocol therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
2	Rush-Presbyterian St. Luke's Medical Center	Chicago	Illinois	United States	60612
3	Medical & Surgical Specialists, LLC	Galesburg	Illinois	United States	61401
4	Cancer Care Center of Southern Indiana	Bloomington	Indiana	United States	47403
5	Oncology Hematology Associates of SW Indiana	Evansville	Indiana	United States	47714
6	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana	United States	46815
7	IN Onc/Hem Associates	Indianapolis	Indiana	United States	46202
8	Indiana University Simon Cancer Center	Indianapolis	Indiana	United States	46202
9	Arnett Cancer Care	Lafayette	Indiana	United States	47904
10	Horizon Oncology Center	Lafayette	Indiana	United States	47905
11	Medical Consultants, P.C.	Muncie	Indiana	United States	47303
12	Monroe Medical Associates	Munster	Indiana	United States	46321
13	Northern Indiana Cancer Research Consortium	South Bend	Indiana	United States	46601
14	Providence Medical Group	Terre Haute	Indiana	United States	47802
15	Ireland Cancer Center - University Hospitals of Cleveland	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Hoosier Cancer Research Network
• Pfizer

Investigators

• Study Chair: Nasser Hanna, M.D., Hoosier Cancer Research Network

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Hoosier Oncology Group Homepage

Publications

• Schmitt JM, Sommers SR, Fisher W, Ansari R, Robin E, Koneru K, McClean J, Liu Z, Tong Y, Hanna N. Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group. J Thorac Oncol. 2012 Apr;7(4):760-3. doi: 10.1097/JTO.0b013e31824abc7c.

• Responsible Party: Nasser Hanna, M.D., Professor, IU School of Medicine, Hoosier Cancer Research Network
• ClinicalTrials.gov Identifier: NCT00730353
• Other Study ID Numbers: HOG GI06-112
• First Posted: Aug 8, 2008
• Last Update Posted: Mar 16, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Esophageal Neoplasms; Paclitaxel; Sunitinib

Study Results

Participant Flow

Recruitment Details	Trial opened to accrual November 2008; opened at both community and academic performance sites.
Pre-assignment Detail	This trial was limited to patients with advanced esophageal cancer.

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Period Title: Overall Study
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Overall Participants	28
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59.5
Sex: Female, Male (Count of Participants)
Female	5 17.9%
Male	23 82.1%
Region of Enrollment (participants) [Number]
United States	28 100%
Eastern Cooperative Oncology Group (ECOG) Performance Status (Number) [Number]
ECOG PS 0	15 53.6%
ECOG PS 1	11 39.3%
ECOG PS 2	2 7.1%
Tumor Site (participants) [Number]
Esophagus	22 78.6%
Gastroesophageal Junction	6 21.4%
Histology (participants) [Number]
Adenocarcinoma	26 92.9%
Squamous cell carcinoma	2 7.1%
Prior Treatment (participants) [Number]
Yes	11 39.3%
No	17 60.7%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival Rate at 24 Weeks
Description	To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat - all enrolled participants

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Measure Participants	28
Number (90% Confidence Interval) [percentage of participants]	25 89.3%

2. Secondary Outcome

Title	Response Rate
Description	To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Evaluable patients, as previously defined.

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Measure Participants	23
Number (90% Confidence Interval) [percentage of participants]	13 46.4%

3. Secondary Outcome

Title	Overall Survival
Description	To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All participants on an intent-to-treat basis

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Measure Participants	28
Median (90% Confidence Interval) [percentage of participants]	20 71.4%

4. Secondary Outcome

Title	Progression-Free Survival
Description	To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat patients

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Measure Participants	28
Median (90% Confidence Interval) [Days]	112

5. Secondary Outcome

Title	Toxicity Profile
Description	Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.
Time Frame	16 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Measure Participants	28
Leukopenia/neutropenia: Grade 3/4	7
Anemia: Grade 3/4	5
Thrombocytopenia	1
Febrile Neutropenia	1

Adverse Events

Time Frame	1 year
Arm/Group Title	Paclitaxel and Sutinib Malate
Arm/Group Description	Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
All Cause Mortality
	Paclitaxel and Sutinib Malate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel and Sutinib Malate
	Affected / at Risk (%)	# Events
Total	14/28 (50%)
Blood and lymphatic system disorders
HEMOGLOBIN	1/28 (3.6%)	1
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER	1/28 (3.6%)	1
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)	1/28 (3.6%)	1
FISTULA, GI / ESOPHAGUS	1/28 (3.6%)	1
HEMORRHAGE, GI / ESOPHAGUS	1/28 (3.6%)	1
HEMORRHAGE, GI / STOMACH	1/28 (3.6%)	1
HEMORRHAGE, GI / UPPER GI NOS	1/28 (3.6%)	1
VOMITING	1/28 (3.6%)	1
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DEATH NOS	1/28 (3.6%)	1
HEMORRHAGE/BLEEDING - OTHER	1/28 (3.6%)	1
WEIGHT LOSS	1/28 (3.6%)	1
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	1/28 (3.6%)	4
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BONE (OSTEOMYELITIS)	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)	1/28 (3.6%)	1
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	1/28 (3.6%)	2
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED	1/28 (3.6%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)	1/28 (3.6%)	1
PAIN / CHEST/THORAX NOS	1/28 (3.6%)	1
PLEURAL EFFUSION (NON-MALIGNANT)	1/28 (3.6%)	1
PULMONARY/UPPER RESPIRATORY - OTHER	2/28 (7.1%)	2
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER	1/28 (3.6%)	1
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM	2/28 (7.1%)	2
Other (Not Including Serious) Adverse Events
	Paclitaxel and Sutinib Malate
	Affected / at Risk (%)	# Events
Total	28/28 (100%)
Blood and lymphatic system disorders
EDEMA: LIMB	3/28 (10.7%)	3
EDEMA: TRUNK/GENITAL	1/28 (3.6%)	1
HEMOGLOBIN	19/28 (67.9%)	40
LEUKOCYTES (TOTAL WBC)	5/28 (17.9%)	21
LYMPHEDEMA-RELATED FIBROSIS	1/28 (3.6%)	1
LYMPHOPENIA	1/28 (3.6%)	2
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	11/28 (39.3%)	32
PLATELETS	5/28 (17.9%)	11
Cardiac disorders
HYPERTENSION	2/28 (7.1%)	2
HYPOTENSION	1/28 (3.6%)	1
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION	1/28 (3.6%)	1
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM	1/28 (3.6%)	1
Endocrine disorders
ENDOCRINE - OTHER	1/28 (3.6%)	1
HOT FLASHES/FLUSHES	3/28 (10.7%)	4
THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)	1/28 (3.6%)	1
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR	2/28 (7.1%)	2
VISION-BLURRED VISION	3/28 (10.7%)	3
WATERY EYE (EPIPHORA, TEARING)	2/28 (7.1%)	2
Gastrointestinal disorders
ANOREXIA	20/28 (71.4%)	24
CONSTIPATION	12/28 (42.9%)	19
DEHYDRATION	3/28 (10.7%)	4
DIARRHEA	12/28 (42.9%)	27
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)	3/28 (10.7%)	3
DYSPHAGIA (DIFFICULTY SWALLOWING)	13/28 (46.4%)	18
FISTULA, GI / ESOPHAGUS	2/28 (7.1%)	2
GASTROINTESTINAL - OTHER	1/28 (3.6%)	1
HEARTBURN/DYSPEPSIA	12/28 (42.9%)	18
HEMORRHAGE, GI / VARICES (RECTAL)	1/28 (3.6%)	1
HEMORRHOIDS	1/28 (3.6%)	1
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ESOPHAGUS	2/28 (7.1%)	4
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY	2/28 (7.1%)	2
NAUSEA	16/28 (57.1%)	24
PAIN / ABDOMEN NOS	9/28 (32.1%)	15
PAIN / ANUS	1/28 (3.6%)	3
PAIN / DENTAL/TEETH/PERIDONTAL	1/28 (3.6%)	1
PAIN / ESOPHAGUS	2/28 (7.1%)	2
PAIN / ORAL-GUMS	1/28 (3.6%)	1
PAIN / RECTUM	1/28 (3.6%)	1
PAIN / STOMACH	1/28 (3.6%)	1
SALIVARY GLAND CHANGES/SALIVA	1/28 (3.6%)	1
TASTE ALTERATION (DYSGEUSIA)	5/28 (17.9%)	8
VOMITING	8/28 (28.6%)	12
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	23/28 (82.1%)	52
FEVER	1/28 (3.6%)	1
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	3/28 (10.7%)	3
HEMORRHAGE/BLEEDING - OTHER	2/28 (7.1%)	3
INSOMNIA	12/28 (42.9%)	18
PAIN / BACK	10/28 (35.7%)	12
PAIN / HEAD/HEADACHE	5/28 (17.9%)	5
PAIN / TUMOR PAIN	1/28 (3.6%)	1
PAIN - OTHER	4/28 (14.3%)	5
RIGORS/CHILLS	5/28 (17.9%)	6
SWEATING (DIAPHORESIS)	2/28 (7.1%)	2
WEIGHT LOSS	5/28 (17.9%)	5
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	2/28 (7.1%)	2
CYTOKINE RELEASE SYNDROME/ACUTE INFUSION REACTION	2/28 (7.1%)	4
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / MUCOSA	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / PENIS	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS	2/28 (7.1%)	2
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS	1/28 (3.6%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS	2/28 (7.1%)	2
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / WOUND	1/28 (3.6%)	1
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	3/28 (10.7%)	3
ALKALINE PHOSPHATASE	9/28 (32.1%)	16
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	4/28 (14.3%)	6
AMYLASE	1/28 (3.6%)	1
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	8/28 (28.6%)	15
BILIRUBIN (HYPERBILIRUBINEMIA)	2/28 (7.1%)	3
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	1/28 (3.6%)	2
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)	7/28 (25%)	12
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)	1/28 (3.6%)	1
LIPASE	1/28 (3.6%)	1
METABOLIC/LABORATORY - OTHER	3/28 (10.7%)	3
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)	2/28 (7.1%)	4
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	1/28 (3.6%)	1
SODIUM, SERUM-LOW (HYPONATREMIA)	5/28 (17.9%)	7
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)	2/28 (7.1%)	2
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER	5/28 (17.9%)	6
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER	1/28 (3.6%)	1
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED	1/28 (3.6%)	1
PAIN / BONE	3/28 (10.7%)	5
PAIN / EXTREMITY-LIMB	5/28 (17.9%)	8
PAIN / JOINT	3/28 (10.7%)	3
Nervous system disorders
DIZZINESS	4/28 (14.3%)	4
NEUROLOGY - OTHER	2/28 (7.1%)	2
NEUROPATHY: MOTOR	1/28 (3.6%)	1
NEUROPATHY: SENSORY	12/28 (42.9%)	14
Psychiatric disorders
MOOD ALTERATION / AGITATION	1/28 (3.6%)	1
MOOD ALTERATION / ANXIETY	8/28 (28.6%)	10
MOOD ALTERATION / DEPRESSION	10/28 (35.7%)	12
Renal and urinary disorders
CYSTITIS	1/28 (3.6%)	1
Respiratory, thoracic and mediastinal disorders
COUGH	12/28 (42.9%)	19
DYSPNEA (SHORTNESS OF BREATH)	13/28 (46.4%)	18
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE	4/28 (14.3%)	5
HICCOUGHS (HICCUPS, SINGULTUS)	2/28 (7.1%)	2
HYPOXIA	1/28 (3.6%)	1
OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS	1/28 (3.6%)	1
PAIN / CHEST WALL	1/28 (3.6%)	1
PAIN / CHEST/THORAX NOS	5/28 (17.9%)	5
PAIN / THROAT/PHARYNX/LARYNX	2/28 (7.1%)	3
PNEUMONITIS/PULMONARY INFILTRATES	1/28 (3.6%)	1
PULMONARY/UPPER RESPIRATORY - OTHER	1/28 (3.6%)	1
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)	2/28 (7.1%)	2
Skin and subcutaneous tissue disorders
DRY SKIN	2/28 (7.1%)	2
FLUSHING	2/28 (7.1%)	2
HAIR LOSS/ALOPECIA (SCALP OR BODY)	13/28 (46.4%)	18
HYPERPIGMENTATION	1/28 (3.6%)	1
INJECTION SITE REACTION/EXTRAVASATION CHANGES	1/28 (3.6%)	1
NAIL CHANGES	1/28 (3.6%)	1
PRURITUS/ITCHING	1/28 (3.6%)	1
RASH/DESQUAMATION	4/28 (14.3%)	5
RASH: ACNE/ACNEIFORM	2/28 (7.1%)	2
RASH: HAND-FOOT SKIN REACTION	3/28 (10.7%)	4
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)	1/28 (3.6%)	1
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ANUS	1/28 (3.6%)	1
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY	5/28 (17.9%)	6
PTT (PARTIAL THROMBOPLASTIN TIME)	1/28 (3.6%)	1

Limitations/Caveats

Statistical power is based on 26 evaluable patients; However, all objectives other than the primary objective were based on 23 evaluable patients.

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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.