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Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003001
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2002

November 1, 1999
July 23, 2008
April 1997
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Complete list of historical versions of study NCT00003001 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: fluorouracil
  • Drug: gemcitabine hydrochloride
  • Drug: leucovorin calcium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
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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

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003001
CDR0000065561, SUNY-HSC-97-2824, NCI-V97-1256
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Stony Brook University
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Study Chair: Stefan Madajewicz, MD, PhD Stony Brook University
National Cancer Institute (NCI)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP