Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

Conditions: Biliary Cancer; Malignant Solid Tumour; Pancreatic Cancer

Treatments: Drug: ZD6474; Drug: Capecitabine; Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00551096

07-0129.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Gemcitabine, capecitabine and ZD6474

Experimental group

Description:

Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2. Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off . ZD6474 administered orally at 300 mg/day once daily. One cycle will consist of 28 days.

Treatment:

Drug: Gemcitabine

Drug: Capecitabine

Drug: ZD6474