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Phase II Trial of Oxaliplatin in Combination With Bolus/Infusional 5FU/LV (FOLFOX4) in Patients With Advanced Gastrointestinal (GI) Cancers With Varying Degrees of Renal Impairment


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Cancer

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Trial Information

Phase II Trial of Oxaliplatin in Combination With Bolus/Infusional 5FU/LV (FOLFOX4) in Patients With Advanced Gastrointestinal (GI) Cancers With Varying Degrees of Renal Impairment


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed locally advanced or
metastatic gastrointestinal (GI) malignancy;

- Patients may have measurable or non-measurable disease;

- Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are
allowed, with the exception that patients cannot have had prior treatment with
oxaliplatin, cisplatin or other nephrotoxic anticancer agent;

- Patients must have had no chemotherapy or radiotherapy within 4 weeks (28 days) prior
to entering the study;

- Age 18 or older;

- Karnofsky performance status of 70% or greater for patients with normal or mildly
abnormal renal function and 50% or greater for patients with moderately or severely
abnormal renal function;

- Life expectancy of at least 3 months;

- Adequate bone marrow function (WBC > or = 3000 cells/mm3, ANC > or = 1500 cells/mm3,
platelets > or = 100,000 cells/mm3);

- Adequate liver function (total bilirubin < or =1.5 times the institutional upper
limit of normal (IULN), AST (SGOT)/ALT (SGPT) < or = 2 times the IULN, unless liver
metastases are present and documented at baseline by CT or MRI scan (< or = 5 times
IULN in that case), alkaline phosphatase < or = 2 times the IULN, unless liver
metastases are present and documented at baseline by CT or MRI scan (< or = 5 times
IULN in that case));

- Patients may have a Grade 1 neurotoxicity at study entry. Absence of deep tendon
reflexes as a sole neurological abnormality does not render the patient ineligible;

- If female, not pregnant or lactating at inclusion. Documentation of a negative serum
HCG pregnancy test for women of child bearing potential is required at inclusion;

- Women of child bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry, for the duration
of study participation and for 6 months after discontinuation of study treatment.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately;

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients with active hydronephrosis (patients with a functioning ureteral stent are
allowed on study);

- Patients who have had chemotherapy or radiotherapy within 4 weeks (28 days) prior to
entering the study;

- Patients who have had a major surgery within 4 weeks (28 days) prior to entering the
study;

- Patients who had prior therapy with oxaliplatin, cisplatin or other nephrotoxic
anticancer agent;

- History of allergy to platinum compounds;

- Patients undergoing therapy with other investigational agents. Patients who received
any investigational drug must have discontinued the investigational drug 30 days or
more before beginning treatment on this study;

- Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency;

- Patients who have had a history of cardiac toxicities while on 5FU/LV therapy or
myocardial infarction < or = 6 months prior to study entry;

- Patients with known brain metastases because of their poor prognosis and because they
often develop progressive neurological dysfunction that would confound the evaluation
of neurological and other toxicities;

- Patients with interstitial pneumonia or extensive and symptomatic fibrosis of the
lungs;

- Patients with uncontrolled intercurrent illness (high blood pressure, unstable angina
pectoris, symptomatic congestive heart failure (NYHA III or IV), severe cardiac
arrhythmia, uncontrolled diabetes or active infection);

- Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events.

Outcome Time Frame:

12 Cycles

Safety Issue:

Yes

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

POP5347

NCT ID:

NCT00094965

Start Date:

September 2004

Completion Date:

August 2007

Related Keywords:

  • Gastrointestinal Cancer
  • Advanced Gastrointestinal tumors and normal to severely abnormal renal function
  • Renal Insufficiency
  • Gastrointestinal Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838