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Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276861
Recruitment Status : Terminated (Low Accrual)
First Posted : January 13, 2006
Results First Posted : February 26, 2013
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
University of Miami

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin 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 gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 2

Detailed Description:



  • Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.


  • Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
  • Determine the duration of response (complete or partial) in patients treated with this regimen.
  • Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving this regimen.
  • Evaluate the toxicity associated with the administration of this regimen in these patients.

OUTLINE: This is a non-randomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
Study Start Date : September 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response Rate as Measured by RECIST Criteria [ Time Frame: 4 - 6 months ]
    Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Secondary Outcome Measures :
  1. Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment [ Time Frame: 6 months ]
    Number of months from time of enrollment to the date of first documented progression or date of death.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the colon

    • Metastatic or recurrent disease
    • Redocumentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy
  • Measurable disease

    • Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by radiographic measurement or any lesion of ≥ 2 cm in longest diameter that 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 measurable or evaluable lesions
  • Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS disease is not required
  • Must have received at least one prior chemotherapy regimen (with or without radiotherapy)

    • One of the prior regimens must include irinotecan hydrochloride, fluorouracil, and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine
    • Previous therapy with C-225 and/or bevacizumab is allowed
  • .


  • ECOG performance status 0-2
  • Granulocyte count ≥1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin < 1.5 mg/dL
  • SGOT ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious medical or psychiatric illness that would render chemotherapy unsafe
  • No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer, low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of the breast
  • No clinical AIDS or known positive HIV serology


  • See Disease Characteristics
  • Recovered from prior therapy
  • No investigational agent for at least 30 days prior to study entry
  • No chemotherapy within the past 3 weeks
  • No radiotherapy for palliation within the past 2 weeks prior to study entry
  • No prior oxaliplatin or gemcitabine hydrochloride
  • No concurrent participation in another clinical trial
  • No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276861

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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center

Publications of Results:
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Responsible Party: University of Miami Identifier: NCT00276861     History of Changes
Other Study ID Numbers: 20030655
SCCC-2003110 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20050993 ( Other Identifier: Western Institutional Review Board )
First Posted: January 13, 2006    Key Record Dates
Results First Posted: February 26, 2013
Last Update Posted: February 8, 2017
Last Verified: December 2016

Keywords provided by University of Miami:
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs