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Status:

COMPLETED

Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-120 years

Phase:

NA

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such...

Detailed Description

OBJECTIVES: Primary * Determine the safety profile of neoadjuvant cetuximab, fluorouracil, and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer. Secondary * ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed rectal adenocarcinoma meeting 1 of the following staging criteria:
  • Locally advanced disease
  • Resectable (uT3) disease
  • Primary gross transmural tumor that is not adherent to adjacent pelvic structures by endorectal ultrasound
  • Primary tethered or unresectable (cT4 or uT4) disease
  • Primary tumor is contiguous with or adherent or fixed to adjacent pelvic structures by clinical exam and CT scan
  • Primary surgery would likely leave residual tumor
  • Small volume extrapelvic metastases allowed
  • Recurrent disease after definitive resection
  • Disease limited to the pelvis
  • Requires combined modality treatment
  • Epidermal growth factor receptor status-positive, -negative, or -unknown
  • If previously treated with adjuvant fluorouracil-based chemotherapy, no disease recurrence during or within 12 months after completion of adjuvant therapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0 -1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin \> 8.0 g/dL
  • Platelet count \> 150,000/mm\^3
  • Hepatic
  • Not specified
  • Renal
  • Creatinine ≤ 1.5 times upper limit of normal
  • Cardiovascular
  • No myocardial infarction within the past 6 months
  • No evidence of uncontrolled congestive heart failure requiring therapy
  • Other
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No known severe hypersensitivity to cetuximab or any of its excipients
  • No uncontrolled infection
  • No high-grade bowel obstruction (bowel lumen ≤ 1 cm) unless patient has undergone protective surgical diversion or endoscopic stenting procedure
  • No other concurrent medical or psychiatric condition or disease that would preclude study participation
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior cetuximab
  • No prior murine or chimeric monoclonal antibody therapy
  • No prior biological response modifiers for metastatic colorectal cancer
  • No concurrent anti-vascular endothelial growth factor/Flk-1 monoclonal antibody therapy
  • No other concurrent antibody therapy or immunotherapy
  • No concurrent gene therapy
  • No concurrent vaccine therapy
  • No concurrent angiogenesis inhibitors, including thalidomide
  • Chemotherapy
  • See Disease Characteristics
  • No prior chemotherapy for metastatic colorectal cancer
  • No other concurrent chemotherapy
  • Endocrine therapy
  • No concurrent hormonal therapy
  • Radiotherapy
  • No prior radiotherapy for metastatic colorectal cancer
  • No prior pelvic radiotherapy
  • No other concurrent radiotherapy
  • Surgery
  • See Disease Characteristics
  • Fully recovered from prior oncologic or other major surgery
  • Other
  • No other prior therapy that targets the epidermal growth factor receptor pathway
  • No other concurrent experimental therapy or drugs
  • No concurrent matrix metalloprotease inhibitors
  • No concurrent participation in another clinical study

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2010

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT00084773

    Start Date

    March 1 2004

    End Date

    March 1 2010

    Last Update

    December 22 2015

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10021