Trial Outcomes & Findings for Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater (NCT NCT00354887)
NCT ID: NCT00354887
Last Updated: 2012-10-29
Results Overview
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
Results posted on
2012-10-29
Participant Flow
Recruitment Period: November 1, 2004 and July 31, 2007. All participants recruited at UT MD Anderson Cancer Center.
Thirty-one patients were enrolled onto the study, and 30 patients received study treatment. One patient did not meet eligibility criteria and did not receive any study treatment. One additional patient was removed from the study after one treatment cycle.
Participant milestones
| Measure |
Oxaliplatin + Capecitabine
Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
Baseline characteristics by cohort
| Measure |
Oxaliplatin + Capecitabine
n=30 Participants
Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.
|
|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responsesPopulation: Analysis was intent-to-treat; One patient developed an acute flare of Crohn's disease after one cycle of study treatment and was removed from study without undergoing restaging scans.
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
Outcome measures
| Measure |
Oxaliplatin + Capecitabine
n=30 Participants
Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.
|
|---|---|
|
Number of Participants With Overall Response
Participants with CR
|
3 participants
|
|
Number of Participants With Overall Response
Participants with PR
|
12 participants
|
Adverse Events
Oxaliplatin + Capecitabine
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxaliplatin + Capecitabine
n=30 participants at risk
Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
56.7%
17/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Belching
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Bilirubin
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Cardiac disorders
Chest Pain
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Cold Intolerance
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Constipation
|
53.3%
16/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Creatinine
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Decreased Total Protein, Serum
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Dehydration
|
10.0%
3/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Diarrhea
|
63.3%
19/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Dizziness
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Eye disorders
Dry Eyes
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.7%
5/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Dry mouth
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Dysphagia
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.3%
7/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Vascular disorders
Edema (limb)
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Elevated phosphorus
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Fatigue
|
73.3%
22/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Fever without neutropenia
|
30.0%
9/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Headache
|
36.7%
11/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Heartburn
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
26.7%
8/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Hemorrhage (abdominal wound)
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.7%
8/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
7/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypoatremia
|
16.7%
5/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
9/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
15/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
3/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Infections and infestations
Infection without neutropenia
|
10.0%
3/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Insomnia
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Reproductive system and breast disorders
Irregular Menses
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Mood alteration(depression)
|
36.7%
11/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Mucositis (Oral Cavity)
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
25/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Neuropathy-Sensory
|
93.3%
28/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Blood and lymphatic system disorders
Neutophils/granulocytes(ANC/AGC)
|
40.0%
12/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Pain (Muscle)
|
46.7%
14/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Musculoskeletal and connective tissue disorders
Pain(joint)
|
40.0%
12/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Pain(throat/larynx)
|
6.7%
2/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Platelets decreased
|
36.7%
11/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
5/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
30.0%
9/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Rash(hand/foot skin reaction)
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Rigors (Chills)
|
26.7%
8/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Serum Glutamic Oxaloacetic Transaminase (AST,SGOT)
|
73.3%
22/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Serum Glutamic Pyruvic Transaminase (ALT,SGPT)
|
40.0%
12/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
General disorders
Taste Alteration
|
30.0%
9/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Total elevated protein
|
13.3%
4/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
10.0%
3/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Vomiting
|
63.3%
19/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Eye disorders
Watery Eyes
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Weight Loss
|
26.7%
8/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.0%
12/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Gastrointestinal disorders
Abdominal bloating
|
10.0%
3/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
30.0%
9/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
6/30 • Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
|
Additional Information
Robert Wolff, MD / Professor
UT MD Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place