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CompletedNCT00043121Updated Dec 11, 2013

Combination Chemotherapy in Treating Patients With Advanced Cancer That is Metastatic or Cannot Be Removed By Surgery

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

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific
03

In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have histologically or cytologically confirmed malignancy which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • There is no limit on prior therapies
  • ECOG performance status 0-2
  • Leukocytes >= 3,000/ul
  • Absolute neutrophil count >= 1,500/ul
  • Platelets >= 100,000/ul
  • Total bilirubin =\< 1.5 mg/dL
  • AST (SGOT)/ALT (SGPT) =\< 2.5 x institutional upper limit of normal
  • Creatinine clearance >= 50 mL/min as calculated by the Cockroft-Gault formula
  • Patients with no >= grade 2 (Common Toxicity Criteria [CTC] 2.0) neuropathy
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Breastfeeding should be discontinued if the mother is treated with oxaliplatin
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Patients undergoing therapy with other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities
  • History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
  • Pregnant and nursing women are excluded from this study because oxaliplatin is a DNA alkylating agent with the potential for teratogenic or abortifacient effects
  • Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Treatment (combination chemotherapy)

    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

Interventions

  • Drugoxaliplatin

    Given IV

    Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

  • Drugleucovorin calcium

    Given IV

    Also known as: CF, CFR, LV

  • Drugfluorouracil

    Given IV

    Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

  • Drugcapecitabine

    Given orally

    Also known as: CAPE, Ro 09-1978/000, Xeloda

  • Otherpharmacological study

    Correlative studies

    Also known as: pharmacological studies

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of adverse events, graded according to NCI CTC version 2.0

    Time frame: Up to 6 years

  2. Overall survival

    Estimated using the product-limit method of Kaplan and Meier.

    Time frame: Up to 6 years

  3. Time to progression

    Estimated using the product-limit method of Kaplan and Meier.

    Time frame: Up to 6 years

  4. Duration of response

    Estimated using the product-limit method of Kaplan and Meier.

    Time frame: Up to 6 years

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Study locations

1 site
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00043121
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jun 2002
Primary completion
Aug 2008
Last update
Dec 11, 2013

Study contacts

George Wilding
principal investigator · University of Wisconsin, Madison
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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