NCT Number: NCT00005839
Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor
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 trial to study the effectiveness of oxaliplatin combined with capecitabine in treating patients who have metastatic or recurrent solid tumors.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Beckman Research Institute, City of Hope, Los Angeles, California, United States
About this study
OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with oxaliplatin in patients with metastatic or recurrent solid tumors. II. Determine the toxicities of this treatment regimen in this patient population.
OUTLINE: This is a dose escalation study of capecitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for disease progression and survival.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2.5 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No evidence of neuropathy No history of allergies to platinum compounds or antiemetics that would preclude study No other uncontrolled illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Prior fluorouracil or cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since prior investigational drugs No concurrent antiretroviral therapy (HAART)
Treatment and study plan
Oxaliplatin
DrugSponsors and collaborators
Lead sponsor
City of Hope Medical Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors
Important dates
- Study start
- 2000
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Apr 21, 2003
- Registry last updated
- Jun 8, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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