Study Of Advanced Gastrointestinal Malignancies And Other Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00660426
First received: April 11, 2008
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

Dose escalation of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.


Condition Intervention Phase
Advanced Gastrointestinal Malignancies
Solid Tumors
Drug: Oxaliplatin
Drug: Gemcitabine
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Of Oxaliplatin, Gemcitabine And Capecitabine In Advanced Gastrointestinal Malignancies And Other Solid Tumors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To define the maximum tolerated dose of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors. [ Time Frame: At the end of dose escalation (approximately 18 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the dose-limiting toxicity of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors. [ Time Frame: Approximately 28 days into treatment ] [ Designated as safety issue: Yes ]
    Completion of 1st cycle

  • To evaluate the incidence and severity of other toxicities of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors. [ Time Frame: 30 days after the end of treatment ] [ Designated as safety issue: Yes ]
  • To perform a structured neurological assessment and questionnaire and report neurological toxicities of oxaliplatin when used with this combination. [ Time Frame: 30 days after end of treatment ] [ Designated as safety issue: Yes ]
  • To perform correlative pharmacogenomic and pharmacokinetic tests for this novel regimen. [ Time Frame: Day 1, 7, 15, and 21 ] [ Designated as safety issue: No ]
    PKs - expanded cohort only


Enrollment: 30
Study Start Date: March 2005
Study Completion Date: April 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1 (starting level)

Oxaliplatin 85 mg/m2 IV on days 1 and 15.

Gemcitabine 800 mg/m2 IV on days 1 and 15.

Capecitabine 600 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet.

Each cycle is 28 days.

Drug: Oxaliplatin Drug: Gemcitabine
Other Name: Gemzar
Drug: Capecitabine
Other Name: Xeloda
Experimental: Dose Level 2

Oxaliplatin 100 mg/m2 IV on days 1 and 15.

Gemcitabine 800 mg/m2 IV on days 1 and 15.

Capecitabine 600 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet.

Each cycle is 28 days.

Drug: Oxaliplatin Drug: Gemcitabine
Other Name: Gemzar
Drug: Capecitabine
Other Name: Xeloda
Experimental: Dose Level 3

Oxaliplatin 100 mg/m2 IV on days 1 and 15.

Gemcitabine 800 mg/m2 IV on days 1 and 15.

Capecitabine 800 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet.

Each cycle is 28 days.

Drug: Oxaliplatin Drug: Gemcitabine
Other Name: Gemzar
Drug: Capecitabine
Other Name: Xeloda
Experimental: Dose Level 4

Oxaliplatin 100 mg/m2 IV on days 1 and 15.

Gemcitabine 1000 mg/m2 IV on days 1 and 15.

Capecitabine 800 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet.

Each cycle is 28 days.

Drug: Oxaliplatin Drug: Gemcitabine
Other Name: Gemzar
Drug: Capecitabine
Other Name: Xeloda

Detailed Description:

To define the maximum tolerated dose of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

  Eligibility

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

Inclusion Criteria:

  1. Histological Diagnosis: Patients must have a histological or cytological proven advanced gastrointestinal or other solid malignancy.
  2. Measurable or Evaluable Disease: See RECIST Criteria: www.cancer.gov/dip/RECIST
  3. Age: Patients must be 18 years old or older. Because no dosing or toxicity data are currently available on the use of oxaliplatin in patients <18 years of age, children are excluded from this study, but will be eligible for other pediatric Phase I single-agent trials, when available.
  4. Performance Status: NCI CTC 0-2.
  5. Life Expectancy: >=8 weeks.
  6. Recovery from Prior Therapy: Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and must be without significant systemic illness (e.g. infection). No chemotherapy or radiotherapy may be given within 3 weeks prior to the start of protocol treatment. Patients must have received <= 2 prior chemotherapy regimes.
  7. Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
  8. Hematological Status: Patients must have adequate bone marrow function which is defined as an absolute neutrophil count >= 1,500/mm³, platelet count >= 100,000/mm³ and hemoglobin >= 9 g/dl.
  9. Hepatic Function: Total bilirubin must be <= institutional limit of normal (ULN). Transaminases (SGOT and/or SGPT) must be <= 4 x ULN.
  10. Neurological Status: Patients must not have active CNS metastases. Patients with Grade 2 or higher peripheral neuropathy are ineligible due to the potential neurological complications of oxaliplatin therapy.
  11. Renal Function: Patients must have adequate renal function defined as serum creatinine <= 2.0 mg/dl or creatinine clearance >= 60 ml/min/1.73m² for patients with creatinine levels above 2.0 mg/dl.
  12. Sexually Active Patients: For all sexually active patients, the use of adequate barrier contraception (hormonal or barrier method of birth control) will be required during therapy, prior to study entry and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential. Pregnant and nursing women patients are not eligible.
  13. HIV-Positive Patients: Patients receiving anti-retroviral therapy (HAART) for HIV infection are excluded from the study because of possible pharmacokinetic interactions. Appropriate protocols will be offered to patients receiving HAART therapy, when indicated.
  14. No known hypersensitivity to oxaliplatin, gemcitabine or capecitabine
  15. No pre-existing clinically significant cardiac, hepatic or renal disease.
  16. Informed Consent: After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
  17. Inclusion of Women and Minorities: Entry to this study is open to both men and women and to all racial and ethnic groups.

Exclusion Criteria:

  • None
  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: NCT00660426

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00660426     History of Changes
Other Study ID Numbers: 04-1213
Study First Received: April 11, 2008
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
cancer
gastrointestinal
tumor

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 02, 2014