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

NCT00290693 | Completed Phase 2 Results DMC

• 4 other identifiers: 20030652SCCC-2003099WIRB-20051007AVENTIS-14056
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Participants Achieving Complete Response or Partial Response to Therapy.

  Rate 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.

  Up to 1 year

Secondary Outcomes (4)

• Overall Surival (OS)

  Up to 1 year

• Progression-free Survival (PFS)

  Up to 1 year

• Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels

  Up to 1 year

• Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy

  Up to 1 year

Study Arms (1)

CapTere (Capecitabine + Docetaxel)

EXPERIMENTAL

Capecitabine + Docetaxel (Taxotere)

Drug: Capecitabine; Drug: Docetaxel

Interventions

Capecitabine DRUG

Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle

Also known as: Xeloda

CapTere (Capecitabine + Docetaxel)

Docetaxel DRUG

30 mg/m2, IV, days 1 and 8 every 3 weeks

Also known as: Taxotere

CapTere (Capecitabine + Docetaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be 18 years or older.
• 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.
• Patients must have metastatic disease.
• Patients with metastatic disease to the brain if they have received radiation therapy or are stable, and are not receiving steroids or anticonvulsants.
• 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.
• Radiation for palliation and of the primary tumor must have been completed at least four weeks prior to initiation of protocol therapy.
• 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.
• Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0,1, or 2.
• 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.
• Required initial laboratory data:
• Granulocytes ≥ 1,500/µl
• Platelets ≥ 100,000/µl
• Hg ≥ 8.0 g/dL
• Creatinine ≤ 2.0 mg/dL

You may not qualify if:

• Patient currently enrolled in another clinical trial.
• 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.
• Participants may not have had capecitabine or docetaxel as part of prior therapy.
• 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.
• Participants with serious uncontrolled medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
• Pregnant or breast-feeding at the time of proposed study entry.
• Clinical AIDS or known positive HIV serology.
• Peripheral neuropathy \> grade 1
• Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 must be excluded.
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
• 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.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Major Surgery within 4 weeks of the start of study treatment, without complete recovery.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Patients with impaired renal function (estimated creatinine clearance \< 30 ml/min as calculated by the Cockroft-Gault Equation).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (3)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Related Publications (1)

• Soares HP, Bayraktar S, Blaya M, Lopes G, Merchan J, Macintyre J, Mayo C, Green MR, Silva O, Levi J, Walker G, Rocha-Lima CM. A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemother Pharmacol. 2014 Apr;73(4):839-45. doi: 10.1007/s00280-014-2414-z. Epub 2014 Feb 23.

  PMID: 24562589 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Caio Max Rocha Lima MD
• Organization: University of Miami Sylvester Comprehensive Cancer Center

crocha@med.miami.edu

305-243-7770

Study Officials

• Caio Max S. Rocha Lima, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: July 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: June 1, 2010
• Last Updated: December 2, 2017
• Results First Posted: May 13, 2013

Record last verified: 2017-10

Locations

US (3)