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Status:

TERMINATED

Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

MacroGenics

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry...

Detailed Description

OBJECTIVES: * To determine the maximum tolerated dose of monoclonal antibody RAV12 when administered with standard gemcitabine hydrochloride in patients with previously untreated metastatic pancreati...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • No prior therapy for metastatic disease (except prior adjuvant chemotherapy and/or radiotherapy)
  • At least 1 radiographically measurable site of disease ≥ 2 cm in the largest dimension by traditional CT technique or ≥ 1 cm by spiral CT scan (per RECIST)
  • No known history of current or prior central nervous system (CNS) metastatic disease
  • PATIENT CHARACTERISTICS:
  • Eastern Cooperative Oncology Group performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase and γ-glutamyltransferase ≤ 2.5 times ULN
  • Amylase and lipase ≤ 1.5 times ULN
  • Total bilirubin ≤ 1.5 times ULN
  • Creatinine \< 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be available for study-related treatments and assessments at the treating institution
  • No known hypersensitivity to any component of gemcitabine hydrochloride
  • No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation
  • No other primary malignancy that has been in remission for ≤ 3 years except treated nonmelanoma skin cancer, biopsy-confirmed carcinoma in situ of the cervix, squamous intraepithelial lesion on Papanicolaou smear, localized prostate cancer with Gleason score \< 6, or resected melanoma in situ
  • No other primary malignancy that has a generally accepted recurrence risk ≥ 10%
  • No active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 4 weeks of enrollment
  • No history of chronic or recurrent infections that require continuous use of antiviral, antifungal, or antibacterial agents
  • No serious underlying medical condition that would impair the patient's ability to receive or tolerate the planned treatment at the investigational site, including significant pulmonary compromise or heart disease of New York Heart Association class III or IV
  • No dementia or altered mental status that would preclude sufficient understanding to provide informed consent
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 4 weeks since prior major surgery
  • More than 4 weeks since prior and no other concurrent investigational agents
  • More than 1 week since prior oral antiviral, antifungal, or antibacterial therapy
  • No concurrent immunosuppressive medications, steroids (except steroid inhaler, ophthalmic solution, nasal spray, or a stable dose of ≤ 10 mg/day of oral prednisone or equivalent), other antineoplastic therapy, or antitumor vaccinations
  • Monoclonal antibody treatment for non-cancer indications must be completed at least 3 half lives from study entry
  • No concurrent prophylactic hematologic growth factors
  • No concurrent megavitamin therapy
  • No concurrent bisphosphonates

Exclusion

    Key Trial Info

    Start Date :

    April 15 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 18 2009

    Estimated Enrollment :

    2 Patients enrolled

    Trial Details

    Trial ID

    NCT00625586

    Start Date

    April 15 2008

    End Date

    March 18 2009

    Last Update

    November 3 2023

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    MacroGenics, Incorporated

    South San Francisco, California, United States, 94080

    2

    Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, United States, 19111-2497