Trial Outcomes & Findings for Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer (NCT NCT00290693)

Last Updated: 2017-12-02

Results Overview

Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2017-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	CapTere (Capecitabine + Docetaxel) Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Overall Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CapTere (Capecitabine + Docetaxel) Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CapTere (Capecitabine + Docetaxel) n=43 Participants * Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks * Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Age, Continuous	64.4 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Number of participants evaluable for response, that is, who completed at least one cycle of protocol therapy.

Outcome measures

Outcome measures
Measure	CapTere (Capecitabine + Docetaxel) n=42 Participants Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Rate of Participants Achieving Complete Response or Partial Response to Therapy. Partial Response (PR) >= 2 cycles	6 participants
Rate of Participants Achieving Complete Response or Partial Response to Therapy. Stable Disease (SD), >= 2 cycles	25 participants
Rate of Participants Achieving Complete Response or Partial Response to Therapy. Complete Response (CR), >= 2 cycles	0 participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Number of participants who completed at least one cycle of protocol therapy.

Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.

Outcome measures

Outcome measures
Measure	CapTere (Capecitabine + Docetaxel) n=42 Participants Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Overall Surival (OS)	5.3 months Interval 4.3 to 8.6

SECONDARY outcome

Timeframe: Up to 1 year

Population: Number of participants who completed at least one cycle of protocol therapy.

Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. 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.

Outcome measures

Outcome measures
Measure	CapTere (Capecitabine + Docetaxel) n=42 Participants Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Progression-free Survival (PFS)	3.7 months Interval 2.1 to 4.3

SECONDARY outcome

Timeframe: Up to 1 year

Population: Participants who had available baseline CA19-9 levels above 100 U/ml.

Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the \> 50% drop can be confirmed with at least one more CA 19-9 level thereafter with \> 50% drop compared to baseline.

Outcome measures

Outcome measures
Measure	CapTere (Capecitabine + Docetaxel) n=31 Participants Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels	35.48 percentage of participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Study participants who received at least one dose of protocol therapy.

Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).

Outcome measures

Outcome measures
Measure	CapTere (Capecitabine + Docetaxel) n=43 Participants Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy	38 participants

Adverse Events

CapTere (Capecitabine + Docetaxel)

Serious events: 25 serious events

Other events: 20 other events

Deaths: 42 deaths

Serious adverse events

Serious adverse events
Measure	CapTere (Capecitabine + Docetaxel) n=43 participants at risk Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
General disorders Fatigue	11.6% 5/43 • Number of events 5 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Vascular disorders Hand and Foot Syndrome	14.0% 6/43 • Number of events 6 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Gastrointestinal disorders Diarrhea	4.7% 2/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Blood and lymphatic system disorders Anemia	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Infections and infestations Mucositis	4.7% 2/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Nervous system disorders Neuropathy	2.3% 1/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Infections and infestations Infection	4.7% 2/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Gastrointestinal disorders Vomiting	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pleural Effusions	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Skin and subcutaneous tissue disorders Nausea	7.0% 3/43 • Number of events 3 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.

Other adverse events

Other adverse events
Measure	CapTere (Capecitabine + Docetaxel) n=43 participants at risk Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
Skin and subcutaneous tissue disorders Alopecia	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Nervous system disorders Neuropathy	4.7% 2/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Infections and infestations Mucositis	4.7% 2/43 • Number of events 2 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Hepatobiliary disorders Hepatotoxicity	2.3% 1/43 • Number of events 1 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Vascular disorders Hand and foot syndrome	11.6% 5/43 • Number of events 5 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Gastrointestinal disorders Diarrhea	7.0% 3/43 • Number of events 3 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Gastrointestinal disorders Nausea	14.0% 6/43 • Number of events 6 Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.

Additional Information

Caio Max Rocha Lima MD

University of Miami Sylvester Comprehensive Cancer Center

Phone: 305-243-7770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place