Trial Outcomes & Findings for Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site (NCT NCT00193609)
NCT ID: NCT00193609
Last Updated: 2013-11-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
18 months
Results posted on
2013-11-11
Participant Flow
Participant milestones
| Measure |
Oxaliplatin/Capecitabine
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Oxaliplatin/Capecitabine
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Baseline characteristics by cohort
| Measure |
Intervention
n=48 Participants
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Age Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsProgression 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
Outcome measures
| Measure |
Intervention
n=44 Participants
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Progression Free Survival
|
3.7 months
Interval 2.6 to 9.7
|
SECONDARY outcome
Timeframe: 18 monthsLength of time, in months, that patients were alive from their first date of protocol treatment until death.
Outcome measures
| Measure |
Intervention
n=44 Participants
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Overall Survival
|
9.7 months
Interval 5.6 to 13.5
|
Adverse Events
Intervention
Serious events: 23 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=48 participants at risk
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
6.2%
3/48 • Number of events 3
|
|
General disorders
fever
|
2.1%
1/48 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain
|
2.1%
1/48 • Number of events 1
|
|
Hepatobiliary disorders
pancreatitis
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
pain
|
2.1%
1/48 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
8.3%
4/48 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression
|
18.8%
9/48 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Upper GI hemorrhage
|
2.1%
1/48 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
left hip fracture
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
adenocarcinoma of recturm
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
4.2%
2/48 • Number of events 2
|
|
Gastrointestinal disorders
paralytic ileus
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
cardiopulmonary arrest
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
CAD with ventricular tachycardia
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
5-FU enteritis
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
hypertension
|
2.1%
1/48 • Number of events 1
|
|
Surgical and medical procedures
intrathecal catheter
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Intervention
n=48 participants at risk
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
8/48 • Number of events 20
|
|
Blood and lymphatic system disorders
Anemia
|
29.2%
14/48 • Number of events 26
|
|
Gastrointestinal disorders
Anorexia
|
39.6%
19/48 • Number of events 48
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
8.3%
4/48 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • Number of events 9
|
|
General disorders
Cold Sensitivity
|
27.1%
13/48 • Number of events 23
|
|
Gastrointestinal disorders
Constipation
|
29.2%
14/48 • Number of events 29
|
|
Gastrointestinal disorders
Dehydration
|
22.9%
11/48 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhea
|
52.1%
25/48 • Number of events 46
|
|
Nervous system disorders
Dizziness
|
8.3%
4/48 • Number of events 7
|
|
Blood and lymphatic system disorders
Edema - NOS
|
29.2%
14/48 • Number of events 39
|
|
General disorders
Fatigue
|
70.8%
34/48 • Number of events 120
|
|
General disorders
Fever
|
8.3%
4/48 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
16.7%
8/48 • Number of events 25
|
|
General disorders
Pain - Head
|
6.2%
3/48 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
3/48 • Number of events 4
|
|
Immune system disorders
Allergic Reaction
|
6.2%
3/48 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
3/48 • Number of events 4
|
|
Infections and infestations
Infection - NOS
|
10.4%
5/48 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
12.5%
6/48 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
72.9%
35/48 • Number of events 71
|
|
Nervous system disorders
Neuropathy
|
52.1%
25/48 • Number of events 62
|
|
Blood and lymphatic system disorders
Neutrophils
|
8.3%
4/48 • Number of events 12
|
|
General disorders
Pain
|
33.3%
16/48 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - NOS
|
14.6%
7/48 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
16.7%
8/48 • Number of events 16
|
|
Gastrointestinal disorders
Taste Alteration
|
8.3%
4/48 • Number of events 12
|
|
Blood and lymphatic system disorders
Platelets
|
35.4%
17/48 • Number of events 59
|
|
Gastrointestinal disorders
Vomiting
|
47.9%
23/48 • Number of events 39
|
|
Metabolism and nutrition disorders
Weight Loss
|
6.2%
3/48 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER