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Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
First Received: February 9, 2006   Last Updated: April 18, 2009   History of Changes
Sponsored by: Sylvester Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290693
  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 II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Docetaxel Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression as measured by the Kaplan Meyer curve [ Designated as safety issue: No ]
  • Toxicity as collected through protocol execution [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: June 2004
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290693

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

Additional Information:
Publications:
Blaya M, Lopes GD, Roman E, et al.: A phase II trial of capecitabine and docetaxel for locally advanced and metastatic pancreatic cancer previously treated with gemcitabine based therapy. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-159, 2007.

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center - Miami ( Caio Max S. Rocha Lima )
Study ID Numbers: CDR0000456363, SCCC-2003099, SCCC-2003/0652C, AVENTIS-14056, WIRB-20051007, FWA00002247
Study First Received: February 9, 2006
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00290693     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Docetaxel
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009