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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
Sponsored by
University of Miami
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Response Rate as Measured by RECIST Criteria
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Secondary Outcome Measures

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.

Full Information

First Posted
January 12, 2006
Last Updated
December 14, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00276861
Brief Title
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Official Title
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Low Accrual
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Response Rate as Measured by RECIST Criteria
Description
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
Time Frame
4 - 6 months
Secondary Outcome Measure Information:
Title
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment
Description
Number of months from time of enrollment to the date of first documented progression or date of death.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caio Max S. Rocha Lima, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17945036
Citation
Lopes G, Quesada J, Ahn E, Flores A, Ribeiro A, Rocha-Lima CM. Oxaliplatin and fixed-rate infusional gemcitabine in the second-line treatment of patients with metastatic colon cancer: final results of a Phase II trial prematurely closed as a result of poor accrual. Clin Colorectal Cancer. 2007 Sep;6(9):641-5. doi: 10.3816/CCC.2007.n.032.
Results Reference
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Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

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