Study Of Advanced Gastrointestinal Malignancies And Other Solid Tumors

Solid Tumors Clinical Trial

Official title:

Phase I Study Of Oxaliplatin, Gemcitabine And Capecitabine In Advanced Gastrointestinal Malignancies And Other Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660426
• Other study ID #: 04-1213
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2008
• Last updated: April 22, 2013
• Start date: March 2005
• Est. completion date: April 2008

Study information

• Verified date: April 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2008
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastrointestinal Malignancies
• Neoplasms
• Solid Tumors

Intervention

Drug:
• Oxaliplatin

• Gemcitabine

• Capecitabine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	To determine the dose-limiting toxicity of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.	Completion of 1st cycle	Approximately 28 days into treatment	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	To perform correlative pharmacogenomic and pharmacokinetic tests for this novel regimen.	PKs - expanded cohort only	Day 1, 7, 15, and 21	No

External Links

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