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Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Solid Tumour; Biliary Cancer; Pancreatic Cancer

Intervention: Gemcitabine (Drug); Capecitabine (Drug); ZD6474 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Stephen Leong, MD, Principal Investigator, Affiliation: University of Colorado, Denver

Summary

Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.

Clinical Details

Official title: A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies.

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine

Detailed description: This phase I study will access a novel regimen using a multi-targeted anti-angiogenic agent which targets the tyrosine kinase of vascular endothelial growth factor (VEGF) receptor 2 and epidermal growth factor receptor (EGFR) in combination with cytotoxic agents: gemcitabine and capecitabine. The rationale is based on observations that there is an additive / synergistic effect when cytotoxic agents are combined with angiogenesis inhibitors. There is also evidence that EGFR mediated signaling pathways are potent stimulators of VEGF production. Also the concept of dual targeting of tumor and endothelial cells may provide more encouraging results.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years or older

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your

ability to perform everyday tasks)

- Life expectancy of at least three months

Blood samples and other testing may apply for further testing of eligibility. Exclusion Criteria:

- Uncontrolled illness (for example, current infections or heart conditions)

- Abnormal laboratory tests (such as blood or urine testing)

- Pregnant or breastfeeding women

Further exclusion criteria may apply.

Locations and Contacts

University of Colorado Denver, Aurora, Colorado 80045, United States
Additional Information

Starting date: October 2007
Last updated: December 23, 2013

Page last updated: August 23, 2015

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