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A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"



- Determine the overall (complete and partial) response rate in patients with recurrent
or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.


- Determine the overall and progression-free survival of patients treated with the
chemotherapy combination.

- Determine the duration of response (complete or partial) among patients who attain a

- Determine the frequency of patients having > 50% fall of CA19-9 from an initial level
of > 100 U/mL in association with treatment with this regimen.

- Evaluate the toxicity associated with the administration of the combination in these

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on
days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 1 year.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically documented adenocarcinoma of the pancreas

- Recurrent or progressive disease

- Metastatic disease

- Metastatic disease to brain allowed if patient has undergone prior radiotherapy
or is stable, and is not receiving steroids or anticonvulsants

- Must have received 1 prior gemcitabine hydrochloride-based regimen (with or without
radiation therapy)

- Measurable tumor, defined as any lesion ≥ 1 cm by spiral CT scan or ≥ 2 cm by
conventional methods

- Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions,
and positive bone marrow biopsies are not considered measurable or evaluable


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 60 days after
completion of study treatment

- ECOG performance status 0, 1, or 2

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Creatinine ≤ 2.0 mg/dL

- Creatine clearance > 30 mL/min

- Bilirubin normal

- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase
(AP) normal OR AP ≤ 4 times ULN AND SGOT and/or SGPT normal

- No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer,
low-grade low-stage bladder carcinoma being followed off therapy, treated in situ
cervical cancer, or lobular neoplasia of the breast

- No serious uncontrolled medical or psychiatric illness that would render chemotherapy

- No clinical AIDS or HIV positivity

- No peripheral neuropathy > grade 1

- No history of severe hypersensitivity reaction to drugs formulated with polysorbate

- No prior unanticipated severe reaction to fluoropyrimidine therapy or known
sensitivity to fluorouracil

- No clinically significant cardiac disease (e.g., congestive heart failure,
symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with
medication) or myocardial infarction within the past 12 months

- No lack of physical integrity of the upper gastrointestinal tract or malabsorption


- See Disease Characteristics

- Recovered from prior therapy

- At least 3 weeks since prior chemotherapy

- At least 30 days since prior experimental agent

- At least 4 weeks since prior palliative radiotherapy for the primary tumor

- No prior capecitabine or docetaxel

- More than 4 weeks since prior major surgery and recovered

- At least 4 weeks since prior sorivudine or brivudine

- No concurrent sorivudine or brivudine

- No concurrent enrollment in another clinical trial

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participant Achieving Complete Response or Partial Response to Therapy.

Outcome Description:

Number 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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

June 2010

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Mayo Clinic - Jacksonville Jacksonville, Florida  32224
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center Miami Beach, Florida  33140