A Phase 1 interventional study of oxaliplatin and leucovorin calcium in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-11.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and best dose of capecitabine when given together with oxaliplatin, leucovorin calcium, and fluorouracil in treating patients with advanced cancer that is metastatic or cannot be removed by surgery. 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.
PRIMARY OBJECTIVES:
I. To establish the MTD and toxicity profile of oral capecitabine in combination with q 2 weekly intravenous oxaliplatin in patients with advanced malignancies.
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetic parameters of capecitabine at the recommended phase II dose for combinations of capecitabine, oxaliplatin, 5-fluorouracil, and leucovorin, as well as for the combination of capecitabine and oxaliplatin.
II. To observe for and record any antitumor activity.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV on days 1 and 15. Patients also receive oral capecitabine every 8 hours on days 1-2 and 15-16. Leucovorin calcium and fluorouracil administration is held at dose level 4 and above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV on days 1 and 15. Patients also receive oral capecitabine every 8 hours on days 1-2 and 15-16. Leucovorin calcium and fluorouracil administration is held at dose level 4 and above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: oxaliplatin · Drug: leucovorin calcium · Drug: fluorouracil · Drug: capecitabine · Other: pharmacological study
Given IV
Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Given IV
Also known as: CF, CFR, LV
Given IV
Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Given orally
Also known as: CAPE, Ro 09-1978/000, Xeloda
Correlative studies
Also known as: pharmacological studies
MTD, defined as the highest dose level which results in DLT in fewer than 2/6 patients, graded according to the NCI CTC version 2.0
Time frame: Up to 28 days
Incidence of adverse events, graded according to NCI CTC version 2.0
Time frame: Up to 6 years
Overall survival
Estimated using the product-limit method of Kaplan and Meier.
Time frame: Up to 6 years
Time to progression
Estimated using the product-limit method of Kaplan and Meier.
Time frame: Up to 6 years
Duration of response
Estimated using the product-limit method of Kaplan and Meier.
Time frame: Up to 6 years
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)