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

OBJECTIVES:

Primary

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

Secondary

- 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
response.

- 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
patients.

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:

1. Participants or their authorized legally acceptable representative must consent to be
in the study and must have signed and dated an approved consent form which conforms to
federal and institutional guidelines.

2. Patients must be 18 years or older.

3. Participants must have recurrence or progression of histologically or cytologically
documented pancreatic adenocarcinoma. Re-documentation of tumor histology or cytology
prior to protocol therapy is not required if documented tumor was confirmed prior to
initial therapy.

4. Patients must have metastatic disease.

5. Patients with metastatic disease to the brain if they have received radiation therapy
or are stable, and are not receiving steroids or anticonvulsants.

6. Participants must have received one prior gemcitabine based chemotherapy regimen (with
or without radiation therapy). Participants must be 3 weeks or more beyond completion
of prior chemotherapy (30 days beyond any experimental agent) and show recovery from
toxicity to within the eligibility parameters of this protocol.

7. Radiation for palliation and of the primary tumor must have been completed at least
four weeks prior to initiation of protocol therapy.

8. Patients must have measurable tumor by Response Evaluation Criteria in Solid Tumors
(RECIST) (Therasse et al, 2000). Measurable disease includes any lesion ≥ 1 cm by
spiral CT or ≥ 2 cm by non-spiral CT in longest diameter which can be repetitively
assessed by radiographic measurement or any lesion ≥ 2 cm in longest diameter which
can be repetitively assessed by physical examination. Positive bone scans,
osteoblastic or osteolytic bone lesions, pleural effusions and positive bone marrow
biopsies are not considered acceptable as either measurable or evaluable lesions.

9. Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status
Score of 0,1, or 2.

10. Females of reproductive potential must not plan on conceiving children during the
treatment period and must agree to use an effective medically accepted form of
contraception. Patients will agree to continue contraception for 60 days from the date
of the last study drug administration.

11. Required initial laboratory data:

- Granulocytes ≥ 1,500/µl

- Platelets ≥ 100,000/µl

- Hg ≥ 8.0 g/dL

- Creatinine ≤ 2.0 mg/dL

- Creatine Clearance >30 ml/min as calculated with Cockroft-Gault equation

- Bilirubin ≤ Upper Limits of Normal (ULN)

- Pregnancy test for females with child-bearing potential: Negative within 7 days
of starting protocol

12. Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of
normal (ULN) if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4
x ULN if transaminases are ≤ ULN.

Exclusion Criteria:

1. Patient currently enrolled in another clinical trial.

2. Pregnant or breast feeding women. With the exception of post-menopausal or infertile
women, a negative blood test for pregnancy is mandatory before entry on study. Fertile
persons refusing to use contraceptives may not participate.

3. Participants may not have had capecitabine or docetaxel as part of prior therapy.

4. No concurrent clinically evident malignancy is allowed except inactive non-melanoma
skin cancer, low grade low stage bladder carcinoma followed off therapy, treated
in-situ cervical cancer or lobular neoplasia of the breast.

5. Participants with serious uncontrolled medical or psychiatric illness that would
render chemotherapy unsafe are ineligible.

6. Pregnant or breast-feeding at the time of proposed study entry.

7. Clinical AIDS or known positive HIV serology.

8. Peripheral neuropathy > grade 1

9. Patients with a history of severe hypersensitivity reaction to drugs formulated with
polysorbate 80 must be excluded.

10. Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil.

11. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 12 months.

12. Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome.

13. Major Surgery within 4 weeks of the start of study treatment, without complete
recovery.

14. Unwillingness to participate or inability to comply with the protocol for the duration
of the study.

15. Patients with impaired renal function (estimated creatinine clearance < 30 ml/min as
calculated by the Cockroft-Gault Equation).