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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00290693
First received: February 9, 2006
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Capecitabine
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: June 2004
Study Completion Date: June 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CapTere (Capecitabine + Docetaxel)
Capecitabine + Docetaxel (Taxotere)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290693

Locations
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00290693     History of Changes
Other Study ID Numbers: UMIAMI-20030652, SCCC-2003099, WIRB-20051007, AVENTIS-14056
Study First Received: February 9, 2006
Results First Received: February 20, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014