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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin. Secondary 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.

Official Title
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Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 . PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate as Measured by RECIST Criteria | Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria. | 4 - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment | Number of months from time of enrollment to the date of first documented progression or date of death. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer