Status:
TERMINATED
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Lead Sponsor:
University of Miami
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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. Givi...
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. Secon...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00276861
Start Date
September 1 2005
End Date
May 1 2008
Last Update
February 8 2017
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136