Trial Outcomes & Findings for Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer (NCT NCT00276861)

Results Overview

Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

4 - 6 months

Results posted on

2017-02-08

Withdrawal data not reported

Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

Baseline characteristics by cohort
Measure	Single Arm n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	58.5 years n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

Timeframe: 4 - 6 months

Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Outcome measures
Measure	Single Arm n=10 Participants
Response Rate as Measured by RECIST Criteria	9.9 percentage of particpants Interval 5.6 to 15.8

Timeframe: 6 months

Number of months from time of enrollment to the date of first documented progression or date of death.

Outcome measures
Measure	Single Arm n=10 Participants
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment	4.6 months Interval 4.2 to 6.1

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events
Measure	Single Arm n=10 participants at risk
Blood and lymphatic system disorders Neutropenia	10.0% 1/10
Infections and infestations Infection	10.0% 1/10

Other adverse events
Measure	Single Arm n=10 participants at risk
Blood and lymphatic system disorders Anemia	70.0% 7/10
Blood and lymphatic system disorders Leukopenia	40.0% 4/10
Gastrointestinal disorders Diarrhea	20.0% 2/10
Nervous system disorders Peripheral Neuropathy	20.0% 2/10
Gastrointestinal disorders Nausea	10.0% 1/10
General disorders Weight Loss	10.0% 1/10

Dept. of Oncology Johns Hopkins Singapore Intl Medical Center

Phone: 656-880-2240