Study Of Advanced Gastrointestinal Malignancies And Other Solid Tumors

NCT00660426 | Completed Phase 1 DMC

• 1 other identifier: 04-1213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Gastrointestinal Malignancies; Solid Tumors

Keywords

cancer; gastrointestinal; tumor

Outcome Measures

Primary Outcomes (1)

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

  At the end of dose escalation (approximately 18 months)

Secondary Outcomes (4)

• To determine the dose-limiting toxicity of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

  Approximately 28 days into treatment

• 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.

  30 days after the end of treatment

• To perform a structured neurological assessment and questionnaire and report neurological toxicities of oxaliplatin when used with this combination.

  30 days after end of treatment

• To perform correlative pharmacogenomic and pharmacokinetic tests for this novel regimen.

  Day 1, 7, 15, and 21

Study Arms (4)

Dose Level 1 (starting level)

EXPERIMENTAL

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; Drug: Capecitabine

Dose Level 2

EXPERIMENTAL

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; Drug: Capecitabine

Dose Level 3

EXPERIMENTAL

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; Drug: Capecitabine

Dose Level 4

EXPERIMENTAL

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; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

Dose Level 1 (starting level); Dose Level 2; Dose Level 3; Dose Level 4

Gemcitabine DRUG

Also known as: Gemzar

Dose Level 1 (starting level); Dose Level 2; Dose Level 3; Dose Level 4

Capecitabine DRUG

Also known as: Xeloda

Dose Level 1 (starting level); Dose Level 2; Dose Level 3; Dose Level 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological Diagnosis: Patients must have a histological or cytological proven advanced gastrointestinal or other solid malignancy.
• Measurable or Evaluable Disease: See RECIST Criteria: www.cancer.gov/dip/RECIST
• 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.
• Performance Status: NCI CTC 0-2.
• Life Expectancy: \>=8 weeks.
• 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.
• 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.
• 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.
• Hepatic Function: Total bilirubin must be \<= institutional limit of normal (ULN). Transaminases (SGOT and/or SGPT) must be \<= 4 x ULN.
• 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.
• 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.
• 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.
• 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.
• No known hypersensitivity to oxaliplatin, gemcitabine or capecitabine
• No pre-existing clinically significant cardiac, hepatic or renal disease.

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Neoplasms

Interventions

Oxaliplatin; Gemcitabine; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Benjamin Tan, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: March 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: April 1, 2008
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)