Trial Outcomes & Findings for Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma (NCT NCT00338988)

Last Updated: 2012-08-01

Results Overview

Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST \[changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria\]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Baseline with restaging every 3 cycles (cycle=21 days)

Results posted on

2012-08-01

Participant Flow

The recruitment period: August 28, 2003 to July 31, 2006. All participants were recruited at UT MD Anderson Cancer Center.

Following enrollment, one of the forty-four participants was found to be ineligible and never assigned to a group.

Participant milestones

Participant milestones
Measure	Capecitabine + Oxaliplatin Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Days 1-14.
Overall Study STARTED	44
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Oxaliplatin n=44 Participants Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Days 1-14.
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants
Age Continuous	68 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline with restaging every 3 cycles (cycle=21 days)

Population: Analysis was per protocol. One participant was found ineligible and received no treatment.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=43 Participants Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Days 1-14.
Number of Participants With Objective Response	1 participants

Adverse Events

Stratum: 1 Prior Regimen

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Stratum 2: No Prior Therapy

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stratum: 1 Prior Regimen n=18 participants at risk Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14.	Stratum 2: No Prior Therapy n=26 participants at risk Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14.
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	3.8% 1/26 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Immune system disorders Allergic Reaction	5.6% 1/18 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	0.00% 0/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Cardiac disorders Congestive Heart Failure	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	3.8% 1/26 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Dehydration	5.6% 1/18 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	0.00% 0/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	0.00% 0/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Nervous system disorders Seizure	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	3.8% 1/26 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	0.00% 0/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.

Other adverse events

Additional Information

Melanie Thomas, MD/Assistant Professor

University Texas MD Anderson Cancer Center

Phone: 713-794-4869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Stratum: 1 Prior Regimen n=18 participants at risk Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14.	Stratum 2: No Prior Therapy n=26 participants at risk Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14.
Skin and subcutaneous tissue disorders Hand-foot skin reaction	22.2% 4/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	30.8% 8/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
General disorders Headache	22.2% 4/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Abdominal Pain	27.8% 5/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	42.3% 11/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Hepatobiliary disorders Alkaline Phosphatase (increase)	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	19.2% 5/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Blood and lymphatic system disorders Anemia	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Anorexia	22.2% 4/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	53.8% 14/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Diarrhea	44.4% 8/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	53.8% 14/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Nervous system disorders Dizziness	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	23.1% 6/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
General disorders Fatigue	50.0% 9/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	69.2% 18/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Flatulence	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	23.1% 6/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Musculoskeletal and connective tissue disorders Jaw cramps	5.6% 1/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Blood and lymphatic system disorders Leukopenia	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	26.9% 7/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	34.6% 9/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Nausea	61.1% 11/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	88.5% 23/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Nervous system disorders Neuropathy-sensory	83.3% 15/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	92.3% 24/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Skin and subcutaneous tissue disorders Rash (Erythema multiform, Desquamation...)	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	3.8% 1/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Hepatobiliary disorders Serum Glutamic Oxaloacetic Transaminase (AST, SGOT)	16.7% 3/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	19.2% 5/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Stomatitis	5.6% 1/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	15.4% 4/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Taste Disturbance	11.1% 2/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	30.8% 8/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 1/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	34.6% 9/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
Gastrointestinal disorders Vomiting	22.2% 4/18 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.	61.5% 16/26 • A total 3 years from August 2003 to December 2006. The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.