A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00660699
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 120
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma Cancer; Gallbladder Cancer; Pancreatic Cancer; Ampullary Cancer	Drug: Gemcitabine; Drug: Docetaxel; Radiation: Radiation	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Arm 1 (gemcitabine, docetaxel, 5FU, radiation) Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Drug: Gemcitabine; Other Names: Gemzar ; Drug: Docetaxel; Other Names: Taxotere ; Radiation: Radiation

Outcome Measures

Primary Outcome Measures

1. Incidence of Severe Toxicities [1 month after completion of treatment (treatment lasts approximately 19 weeks)]

   Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0

Secondary Outcome Measures

1. Toxicities Associated With Treatment (Grade 1-2) [30 days after completion of treatment (treatment lasts approximately 19 weeks)]

   Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.

2. Toxicities Associated With Treatment (Grade 3-4) [30 days after completion of treatment (treatment lasts approximately 19 weeks)]

   Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.

3. Disease Free Survival (DFS) - Median [Median follow-up was 24 months (range 3.2-97 months)]

   DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.

4. Overall Survival (OS) - Median [Median follow-up was 24 months (range 3.2-97 months)]

   OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.

5. Overall Survival (OS) [1 year]

   OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

6. Overall Survival (OS) [2 years]

   OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.

• Patients must be 18 years or older.

• Patients must have a NCI CTC Performance Status of 0-2.

• Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.

• At least 3 weeks should have elapsed since any surgery requiring general anesthesia.

• Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years

• Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.

• Initial Required Laboratory Values:

• Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.

• Serum creatinine should be ≤ 2 mg/dL.

• Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).

• Serum transaminases should be ≤ 5-fold the institutional upper limits.

• Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.

• Patients must be able to sign an informed consent.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	St. Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Benjamin Tan, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00660699
• Other Study ID Numbers: 02-0580 / 201101866
• First Posted: Apr 17, 2008
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Keywords provided by Washington University School of Medicine: Cholangiocarcinoma; Gallbladder; Pancreatic; Ampullary; Cancer
• Additional relevant MeSH terms: Cholangiocarcinoma; Gallbladder Neoplasms; Gemcitabine; Docetaxel

Study Results

Participant Flow

Recruitment Details	The study opened to participants enrollment on 09/14/2002 and closed to participant enrollment on 11/06/2012

Arm/Group Title	Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Period Title: Overall Study
STARTED	50
COMPLETED	48
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Overall Participants	50
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	29 58%
Male	21 42%
Region of Enrollment (participants) [Number]
United States	50 100%
Overall stage (participants) [Number]
I	3 6%
II	46 92%
III	1 2%
IV	0 0%
Disease type (participants) [Number]
Pancreatic cancer	29 58%
Biliary tract cancer	12 24%
Ampullary cancer	9 18%
T-stage (participants) [Number]
1	2 4%
2	11 22%
3	35 70%
4	2 4%
N-stage (participants) [Number]
0	10 20%
1	36 72%
X	4 8%
Differentiation (participants) [Number]
Well	4 8%
Moderate	17 34%
Poor	28 56%
Not reported	1 2%
Lymphovascular involvement (participants) [Number]
Yes	36 72%
No	9 18%
Not Reported	5 10%
CA 19-9 (tumor marker) (participants) [Number]
<40	34 68%
40-100	11 22%
>100	5 10%

Outcome Measures

1. Primary Outcome

Title	Incidence of Severe Toxicities
Description	Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Time Frame	1 month after completion of treatment (treatment lasts approximately 19 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Number [percentage of participants]	20 40%

2. Secondary Outcome

Title	Toxicities Associated With Treatment (Grade 1-2)
Description	Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.
Time Frame	30 days after completion of treatment (treatment lasts approximately 19 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Mucositis	31 62%
Nausea	48 96%
Vomiting	23 46%
Diarrhea	31 62%
Dehydration	17 34%
Weight loss	27 54%
Fatigue	67 134%
Renal toxicity	13 26%
Hepatotoxicity	69 138%
Infection	13 26%
Neutropenia	46 92%
Anemia	65 130%
Thrombocytopenia	46 92%

3. Secondary Outcome

Title	Toxicities Associated With Treatment (Grade 3-4)
Description	Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.
Time Frame	30 days after completion of treatment (treatment lasts approximately 19 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Mucositis	2 4%
Nausea	4 8%
Vomiting	4 8%
Diarrhea	15 30%
Dehydration	4 8%
Weight loss	0 0%
Fatigue	8 16%
Renal toxicity	0 0%
Hepatotoxicity	4 8%
Infection	15 30%
Neutropenia	23 46%
Anemia	4 8%
Thrombocytopenia	6 12%

4. Secondary Outcome

Title	Disease Free Survival (DFS) - Median
Description	DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Time Frame	Median follow-up was 24 months (range 3.2-97 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Pancreatic cancer	9.6
Biliary/ampullary cancer	12.7

5. Secondary Outcome

Title	Disease Free Survival (DFS) - Median
Description	DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Time Frame	Median follow-up was 24 months (range 3.2-97 months)

Outcome Measure Data

Analysis Population Description

30 out of 48 participants completed all components of the study therapy.

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	30
Pancreatic cancer	12.8
Biliary cancer/ampullary cancer	15.0

6. Secondary Outcome

Title	Overall Survival (OS) - Median
Description	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Time Frame	Median follow-up was 24 months (range 3.2-97 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Pancreatic cancer	17.6
Biliary cancer/ampullary cancer	23.8

7. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Pancreatic cancer	60.7 121.4%
Biliary/ampullary cancer	75.0 150%

8. Post-Hoc Outcome

Title	Incidence of Disease Recurrence
Time Frame	Median follow-up was 24 months (range 3.2-97 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Number [percentage of participants]	83 166%

9. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	48
Pancreatic cancer	32.1 64.2%
Biliary/ampullary cancer	49.1 98.2%

10. Secondary Outcome

Title	Overall Survival (OS) - Median
Description	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Time Frame	Median follow-up was 24 months (range 3.2-97 months)

Outcome Measure Data

Analysis Population Description

30 out of 48 participants completed all components of study treatment.

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	30
Pancreatic cancer	24.5
Biliary cancer/ampullary cancer	23.8

11. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

30 out of 48 participants completed all components of study treatment.

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Measure Participants	30
Pancreatic cancer	78.6 157.2%
Biliary/ampullary cancer	81.2 162.4%

Adverse Events

Arm/Group Title	Arm 1
Arm/Group Description	Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	16/48 (33.3%)
Blood and lymphatic system disorders
Hemoglobin	1/48 (2.1%)
Gastrointestinal disorders
Abdominal cystic lesion	1/48 (2.1%)
Constipation	1/48 (2.1%)
Dehydration	1/48 (2.1%)
Diarrhea	2/48 (4.2%)
Ileus, GI	1/48 (2.1%)
Nausea	1/48 (2.1%)
Vomiting	2/48 (4.2%)
General disorders
Death	1/48 (2.1%)
Edema	1/48 (2.1%)
Fever	3/48 (6.3%)
Generalized weakness	1/48 (2.1%)
Pain	1/48 (2.1%)
Infections and infestations
Febrile neutropenia	1/48 (2.1%)
Infection	6/48 (12.5%)
Investigations
Granulocytes	1/48 (2.1%)
Leukopenia	1/48 (2.1%)
Platelets	1/48 (2.1%)
Metabolism and nutrition disorders
Hypokalemia	1/48 (2.1%)
Hypomagnesemia	1/48 (2.1%)
Hyponatremia	1/48 (2.1%)
Nervous system disorders
Dizziness	1/48 (2.1%)
Syncope	1/48 (2.1%)
Respiratory, thoracic and mediastinal disorders
Cavitary lung lesion	1/48 (2.1%)
Pleural effusion	1/48 (2.1%)
Vascular disorders
Hypotension	1/48 (2.1%)
Thrombosis/embolism	1/48 (2.1%)
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	48/48 (100%)
Blood and lymphatic system disorders
Hemoglobin	32/48 (66.7%)
Eye disorders
Eye	1/48 (2.1%)
Gastrointestinal disorders
Ascites	2/48 (4.2%)
Colitis	1/48 (2.1%)
Constipation	8/48 (16.7%)
Dehydration	9/48 (18.8%)
Diarrhea	21/48 (43.8%)
Dyspepsia	4/48 (8.3%)
Dysphagia	1/48 (2.1%)
Flatulence	1/48 (2.1%)
Hematochezia	1/48 (2.1%)
Mucositis	11/48 (22.9%)
Nausea	23/48 (47.9%)
Stomatitis	2/48 (4.2%)
Vomiting	1/48 (2.1%)
Weight loss	8/48 (16.7%)
General disorders
Chills	2/48 (4.2%)
Edema	3/48 (6.3%)
Fatigue	34/48 (70.8%)
Fever	2/48 (4.2%)
Hemorrhage	2/48 (4.2%)
Pain	25/48 (52.1%)
Sweating	1/48 (2.1%)
Infections and infestations
Infection	7/48 (14.6%)
Thrush	1/48 (2.1%)
Investigations
Alkaline phosphatase	18/48 (37.5%)
BUN	2/48 (4.2%)
Bilirubin	1/48 (2.1%)
Granulocytes	28/48 (58.3%)
Leukopenia	32/48 (66.7%)
Lymphopenia	33/48 (68.8%)
Platelets	24/48 (50%)
SGOT/SGPT	26/48 (54.2%)
Metabolism and nutrition disorders
Anorexia	11/48 (22.9%)
Hypercalcemia	4/48 (8.3%)
Hyperglycemia	24/48 (50%)
Hyperkalemia	2/48 (4.2%)
Hypoalbuminemia	25/48 (52.1%)
Hypocalcemia	16/48 (33.3%)
Hypoglycemia	2/48 (4.2%)
Hypokalemia	9/48 (18.8%)
Hypomagnesemia	1/48 (2.1%)
Hyponatremia	9/48 (18.8%)
Hypophosphatemia	1/48 (2.1%)
Nervous system disorders
Dizziness	1/48 (2.1%)
Dysgeusia	1/48 (2.1%)
Other neurologic	1/48 (2.1%)
Sensory neuropathy	2/48 (4.2%)
Psychiatric disorders
Anxiety	1/48 (2.1%)
Depression	5/48 (10.4%)
Insomnia	4/48 (8.3%)
Renal and urinary disorders
Creatinine	6/48 (12.5%)
Hematuria	2/48 (4.2%)
Nocturia	1/48 (2.1%)
Proteinuria	3/48 (6.3%)
Urinary retention	1/48 (2.1%)
Urinary tract infection	3/48 (6.3%)
Respiratory, thoracic and mediastinal disorders
Cough	2/48 (4.2%)
Skin and subcutaneous tissue disorders
Alopecia	2/48 (4.2%)
Erythema	1/48 (2.1%)
Hand/foot syndrome	5/48 (10.4%)
Rash	2/48 (4.2%)
Skin-photosensitivity	1/48 (2.1%)
Vascular disorders
Flushing	1/48 (2.1%)
Hypertension	1/48 (2.1%)
Hypotension	3/48 (6.3%)
Phlebitis	1/48 (2.1%)
Thrombosis/embolism	2/48 (4.2%)

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.