Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00003001|
Recruitment Status : Unknown
Verified April 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 29, 2004
Last Update Posted : July 24, 2008
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||April 29, 2004|
|Last Update Posted Date||July 24, 2008|
|Start Date ICMJE||April 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003001 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer|
|Official Title ICMJE||Phase I/II Study of 5-Fluorouracil/Folinic Acid/Gemcitabine in Patients With Advanced Colorectal Carcinoma|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.
OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin calcium, and gemcitabine in these patients.
OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to be considered evaluable for response. Patients with stable disease, partial, or complete remission may continue therapy for up to six treatment cycles. Patients exhibiting disease progression or intolerable toxic effects are removed from the study.
PROJECTED ACCRUAL: A total of 63 patients will be accrued.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Colorectal Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||63|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic primary colorectal carcinoma Must have measurable disease (evaluable disease acceptable in Phase I)
PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-3 Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL OR 3.0 mg/dL in patients with liver metastases Liver enzymes no greater than 3.0 times upper limit of normal (in patients with liver metastases) Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for metastatic disease allowed Prior treatment with 5-FU allowed Prior treatment with irinotecan allowed Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy (measurable disease must be located outside the prior radiotherapy portal) Surgery: Not specified Other: Prior treatment with folinic acid allowed
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00003001|
|Other Study ID Numbers ICMJE||CDR0000065561
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Stony Brook University|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||April 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP