Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00005839
First received: June 2, 2000
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: capecitabine
Drug: oxaliplatin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Study Start Date: August 2000
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005839

Locations
United States, California
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: Heinz-Josef Lenz, MD University of Southern California
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005839     History of Changes
Other Study ID Numbers: CDR0000067854, U01CA062505, CHNMC-PHI-25, CHNMC-IRB-99130, NCI-T99-0005
Study First Received: June 2, 2000
Last Updated: January 13, 2010
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014