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

• Number of Participant Achieving Complete Response or Partial Response to Therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  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.
• Number of Participants Achieving a 50% or More Reduction in CA 19-9 Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Number 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.

• Time to Progression as Measured by the Kaplan Meyer Curve [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Toxicity as Collected Through Protocol Execution [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works 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.

• Drug: Capecitabine
  Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
  Other Name: Xeloda
• Drug: Docetaxel
  30 mg/m2, IV, days 1 and 8 every 3 weeks
  Other Name: Taxotere

DISEASE CHARACTERISTICS:

• 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 disease

PATIENT CHARACTERISTICS:

• 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 unsafe
• No clinical AIDS or HIV positivity
• No peripheral neuropathy > grade 1
• No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
• 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 syndrome

PRIOR CONCURRENT THERAPY:

• 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