S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00335959
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 7
• Locations: 75
• Arm: 1
• Patients Per Site: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

• Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.)

• Assess the frequency and severity of toxicities associated with this regimen.

• Explore, preliminarily, the association between DNA repair genes (ERCC-1, XRCC1, GST-P1, XPD, XPA, ribonucleotide reductase), target enzymes (thymidylate synthase [TS], dihydropyrimidine dehydrogenase, thymidine phosphorylase [TP]), and angiogenic factors (vascular endothelial growth factor [VEGF], epidermal growth factor [EGF], PD-ECGF, basic fibroblast growth factor, TSP-1 and -2, transforming growth factor [TGF]-β, and IL-8) and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach. (This will not be completed as this study was closed early due to poor accrual.)

• Explore, preliminarily, the association of haplotypes of candidate genes of TS, TP, ERCC-1, XPD, GST-P1, cyclooxygenase-2, EGF receptor, TGF-β, VEGF, and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients. (This will not be completed as this study was closed early due to poor accrual.)

• Explore, preliminarily, the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy. (This will not be completed as this study was closed early due to poor accrual.)

OUTLINE: This is a multicenter, pilot study.

• Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity.

• Neoadjuvant chemoradiotherapy: Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47, 50-54, 57-61, 64-68, and 71-75 in the absence of disease progression or unacceptable toxicity.

• Surgery: Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy.

Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Chemotherapy, Chemoradiation, Surgery Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

Drug: capecitabine; 850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.; Other Names: Xeloda (NSC-712807) ; Drug: oxaliplatin; 130 mg/m2 by 2-hour infusion Days 1 and 22; Other Names: Eloxatin (NSC-266046) ; Procedure: conventional surgery; Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy; Other Names: gastrectomy ; Radiation: radiation therapy; Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.; Other Names: RT

Outcome Measures

Primary Outcome Measures

1. Pathologic Complete Response [17-19 weeks]

   Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.

Secondary Outcome Measures

1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.]

   Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:

• Newly diagnosed disease amenable to curative resection

• Stage IB-III (T2-4)

• Measurable or nonmeasurable disease

• Enlarged lymph nodes outside of radiation fields must have preoperative biopsies

• No positive lymph nodes outside of radiation fields

• No distant metastasis

• No gastroesophageal junction tumors

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• WBC ≥ 3,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 times upper limit of normal

• Albumin ≥ 3 g/dL

• Bilirubin normal

• No evidence of ischemic heart disease by EKG

• No coronary artery disease requiring active medical treatment

• No symptoms of angina

• No history of myocardial infarction

• No deep vein thrombosis within the past 12 months

• No pre-existing peripheral neuropathy

• No active pneumonia or inflammatory lung infiltrate

• No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years

• No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no concurrent sorivudine or brivudine

• No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy

• No prior coronary angioplasty or stenting

• No concurrent 2-dimensional or intensity-modulated radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
3	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
4	Desert Regional Medical Center Comprehensive Cancer Center	Palm Springs	California	United States	92262
5	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
6	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
7	Shaw Regional Cancer Center	Edwards	Colorado	United States	81632
8	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
9	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia	United States	31405
10	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
11	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
12	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
13	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
14	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
15	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
16	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
17	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
18	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
19	Holland Community Hospital	Holland	Michigan	United States	49423
20	Hackley Hospital	Muskegon	Michigan	United States	49442
21	Munson Medical Center	Traverse City	Michigan	United States	49684
22	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
23	St. John's Regional Health Center	Springfield	Missouri	United States	65804
24	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
25	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
26	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
27	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
28	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
29	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
30	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
31	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
32	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
33	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
34	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
35		Great Falls	Montana	United States	59405
36	St. Peter's Hospital	Helena	Montana	United States	59601
37	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
38	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
39	Community Medical Center	Missoula	Montana	United States	59801
40	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
41	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
42	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
43	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
44	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
45	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
46	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
47	Grandview Hospital	Dayton	Ohio	United States	45405
48	Good Samaritan Hospital	Dayton	Ohio	United States	45406
49	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
50	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
51	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
52	CCOP - Dayton	Dayton	Ohio	United States	45429
53	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
54	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
55	Middletown Regional Hospital	Middletown	Ohio	United States	45044
56	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
57	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
58	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
59	Medical City Dallas Hospital	Dallas	Texas	United States	75230
60	Danville Regional Medical Center	Danville	Virginia	United States	24541
61	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
62	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
63	Columbia Basin Hematology	Kennewick	Washington	United States	99336
64	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington	United States	98273
65	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
66	Harborview Medical Center	Seattle	Washington	United States	98104
67	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
68	Group Health Central Hospital	Seattle	Washington	United States	98112
69	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
70	Polyclinic First Hill	Seattle	Washington	United States	98122
71	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
72	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
73	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
74	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
75	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Lawrence P. Leichman, MD, Desert Regional Medical Center Comprehensive Cancer Center
• Study Chair: Syed A. Ahmad, MD, Barrett Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00335959
• Other Study ID Numbers: CDR0000476577; U10CA032102; S0425
• First Posted: Jun 12, 2006
• Last Update Posted: Aug 17, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Southwest Oncology Group: adenocarcinoma of the stomach; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer
• Additional relevant MeSH terms: Stomach Neoplasms; Capecitabine; Oxaliplatin

Study Results

Participant Flow

Arm/Group Title	Chemotherapy, Chemoradiation, Surgery
Arm/Group Description	Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Period Title: Overall Study
STARTED	7
Eligible	6
Eligible and Began Protocol Therapy	6
COMPLETED	4
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Chemotherapy, Chemoradiation, Surgery
Arm/Group Description	Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Overall Participants	6
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	72
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 16.7%
Not Hispanic or Latino	3 50%
Unknown or Not Reported	2 33.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 33.3%
White	3 50%
More than one race	0 0%
Unknown or Not Reported	1 16.7%

Outcome Measures

1. Secondary Outcome

Title	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Description	Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.
Time Frame	Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.

Outcome Measure Data

Analysis Population Description

Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Arm/Group Title	Chemotherapy, Chemoradiation and Surgery
Arm/Group Description	Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Measure Participants	6
Anorexia	1 16.7%
Dehydration	2 33.3%
Diarrhea	2 33.3%
Fatigue (asthenia, lethargy, malaise)	1 16.7%
Gastrointestinal-Other (Specify)	1 16.7%
Hemoglobin	1 16.7%
Leukocytes (total WBC)	1 16.7%
Lymphopenia	2 33.3%
Nausea	1 16.7%
Necrosis, GI - Small bowel NOS	1 16.7%
Neutrophils/granulocytes (ANC/AGC)	1 16.7%
Phosphate, serum-low (hypophosphatemia)	1 16.7%
Platelets	1 16.7%
Potassium, serum-low (hypokalemia)	1 16.7%
Sodium, serum-low (hyponatremia)	1 16.7%
Vomiting	1 16.7%

2. Primary Outcome

Title	Pathologic Complete Response
Description	Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.
Time Frame	17-19 weeks

Outcome Measure Data

Analysis Population Description

Eligible patients who completed pre-operative therapy were assessed for response.

Arm/Group Title	Chemotherapy, Chemoradiation, Surgery
Arm/Group Description	Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
Measure Participants	5
Unconfirmed Complete Response	1 16.7%
Unconfirmed Partial Response	2 33.3%
Stable/No Response	2 33.3%
Increasing Disease	1 16.7%
Assessment Inadequate	1 16.7%

Adverse Events

Time Frame	Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Arm/Group Title	Chemotherapy, Chemoradiation and Surgery
Arm/Group Description	Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
All Cause Mortality
	Chemotherapy, Chemoradiation and Surgery
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Chemotherapy, Chemoradiation and Surgery
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Gastrointestinal disorders
Gastrointestinal-Other (Specify)	1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Chemotherapy, Chemoradiation and Surgery
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Blood and lymphatic system disorders
Hemoglobin	4/6 (66.7%)
Cardiac disorders
Ventricular arrhythmia - PVCs	1/6 (16.7%)
Gastrointestinal disorders
Constipation	1/6 (16.7%)
Diarrhea	3/6 (50%)
Dysphagia (difficulty swallowing)	1/6 (16.7%)
Heartburn/dyspepsia	1/6 (16.7%)
Mucositis/stomatitis (clinical exam) - Oral cavity	1/6 (16.7%)
Mucositis/stomatitis (functional/symptomatic) - Oral cavity	1/6 (16.7%)
Nausea	6/6 (100%)
Necrosis, GI - Small bowel NOS	1/6 (16.7%)
Pain - Abdomen NOS	1/6 (16.7%)
Pain - Esophagus	1/6 (16.7%)
Pain - Intestine	1/6 (16.7%)
Pain - Stomach	1/6 (16.7%)
Vomiting	3/6 (50%)
General disorders
Fatigue (asthenia, lethargy, malaise)	6/6 (100%)
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary tract	1/6 (16.7%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	1/6 (16.7%)
AST, SGOT (serum glutamic oxaloacetic transaminase)	1/6 (16.7%)
Alkaline phosphatase	1/6 (16.7%)
Creatinine	2/6 (33.3%)
Leukocytes (total WBC)	4/6 (66.7%)
Lymphopenia	2/6 (33.3%)
Neutrophils/granulocytes (ANC/AGC)	2/6 (33.3%)
Platelets	2/6 (33.3%)
Weight loss	2/6 (33.3%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	1/6 (16.7%)
Anorexia	2/6 (33.3%)
Calcium, serum-high (hypercalcemia)	1/6 (16.7%)
Calcium, serum-low (hypocalcemia)	1/6 (16.7%)
Dehydration	2/6 (33.3%)
Glucose, serum-high (hyperglycemia)	2/6 (33.3%)
Phosphate, serum-low (hypophosphatemia)	1/6 (16.7%)
Potassium, serum-low (hypokalemia)	3/6 (50%)
Sodium, serum-low (hyponatremia)	1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Pain - Joint	1/6 (16.7%)
Nervous system disorders
Neuropathy: sensory	4/6 (66.7%)
Psychiatric disorders
Mood alteration - anxiety	1/6 (16.7%)
Skin and subcutaneous tissue disorders
Dry skin	1/6 (16.7%)
Photosensitivity	1/6 (16.7%)
Rash: hand-foot skin reaction	1/6 (16.7%)
Vascular disorders
Hypotension	1/6 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

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.