Trial Outcomes & Findings for Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer (NCT NCT00320749)
NCT ID: NCT00320749
Last Updated: 2016-06-27
Results Overview
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
COMPLETED
PHASE1
21 participants
Weekly up to 24 weeks
2016-06-27
Participant Flow
Patients were enrolled into the study between December 2005 and February 2008.
Patients had histologically or cytologically confirmed metastatic pancreatic adenocarcinoma and measurable disease per RECIST criteria.
Participant milestones
| Measure |
Dose Level 1
Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
|
Dose Level 2
Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
|
Dose Level 3
Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
10
|
|
Overall Study
COMPLETED
|
3
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine, Gemcitabine and Docetaxel
n=21 Participants
Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
|
|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG 0 (Fully Active)
|
4 patients
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG 1 (Restricted physical activity)
|
17 patients
n=99 Participants
|
PRIMARY outcome
Timeframe: Weekly up to 24 weeksMTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
Outcome measures
| Measure |
Capecitabine, Docetaxel, Gemcitabine
n=21 Participants
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
Capecitabine: Will be give on days 8-21
Docetaxel: Will be given on days 1 and 8,
Gemcitabine: A fixed dose rate will be give on days 8 and 15.
|
|---|---|
|
Maximum Tolerated Dose (MTD)
docetaxel
|
36 mg/m^2
|
|
Maximum Tolerated Dose (MTD)
gemcitabine
|
750 mg/m^2
|
|
Maximum Tolerated Dose (MTD)
capecitabine
|
625 mg/m^2
|
SECONDARY outcome
Timeframe: Weekly up to 24 weeksPopulation: grade 3 and grade 4 toxicities according to National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 3.0
The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.
Outcome measures
| Measure |
Capecitabine, Docetaxel, Gemcitabine
n=21 Participants
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
Capecitabine: Will be give on days 8-21
Docetaxel: Will be given on days 1 and 8,
Gemcitabine: A fixed dose rate will be give on days 8 and 15.
|
|---|---|
|
Common Toxicities
leukopenia
|
29 percent of patients
|
|
Common Toxicities
neutropenia
|
29 percent of patients
|
|
Common Toxicities
fatigue
|
25 percent of patients
|
SECONDARY outcome
Timeframe: every 8 weeks, up to 24 weeksPopulation: 3 patients were non-evaluable for response or progression free survival as they withdrew consent after cycle 1 of therapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Capecitabine, Docetaxel, Gemcitabine
n=18 Participants
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
Capecitabine: Will be give on days 8-21
Docetaxel: Will be given on days 1 and 8,
Gemcitabine: A fixed dose rate will be give on days 8 and 15.
|
|---|---|
|
Therapeutic Response
Partial Response
|
11 percent of patients
|
|
Therapeutic Response
Complete Response
|
0 percent of patients
|
|
Therapeutic Response
Stable Disease
|
72 percent of patients
|
Adverse Events
Capecitabine, Docetaxel, Gemcitabine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Capecitabine, Docetaxel, Gemcitabine
n=21 participants at risk
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
14/21 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.4%
11/21 • Number of events 11
|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
10/21 • Number of events 10
|
|
Injury, poisoning and procedural complications
Thrombocytopenia
|
47.6%
10/21 • Number of events 10
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 18
|
|
Gastrointestinal disorders
Nausea
|
76.2%
16/21 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhea
|
76.2%
16/21 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
61.9%
13/21 • Number of events 13
|
|
Nervous system disorders
Neuropathy
|
52.4%
11/21 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
38.1%
8/21 • Number of events 8
|
|
Gastrointestinal disorders
Mucositis
|
33.3%
7/21 • Number of events 7
|
|
Infections and infestations
Transaminitis
|
23.8%
5/21 • Number of events 5
|
Additional Information
Tanios Bekaii-Saab, M.D.
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place