Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

NCT00551096 | Completed Phase 1 DMC

• 1 other identifier: 07-0129.cc
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Solid Tumour; Biliary Cancer; Pancreatic Cancer

Keywords

Advanced Solid Tumors; Biliary or Pancreatic Malignancies

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine

  To evaluate the safety profile and determine the MTD dose of ZACTIMA in combination with Gemcitabine and Capecitabine in patients with advanced malignancies. Toxicity will be graded per Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0 and adverse event reporting for this study will be performed via Adverse Event Expedited Reporting System (AdEERS). All patients who receive any amount of the study drug will be evaluable for toxicity.

  Up to 28 days

Study Arms (1)

Gemcitabine, capecitabine and ZD6474

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Capecitabine; Drug: ZD6474

Interventions

Gemcitabine DRUG

Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.

Also known as: Gemzar

Gemcitabine, capecitabine and ZD6474

Capecitabine DRUG

Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.

Also known as: Xeloda

Gemcitabine, capecitabine and ZD6474

ZD6474 DRUG

Administered orally at 300 mg/day once daily. One cycle will consist of 28 days

Also known as: Zactima

Gemcitabine, capecitabine and ZD6474

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled illness (for example, current infections or heart conditions)
• Abnormal laboratory tests (such as blood or urine testing)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University of Colorado, Denver: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Kessler ER, Eckhardt SG, Pitts TM, Bradshaw-Pierce EL, O'byrant CL, Messersmith WA, Nallapreddy S, Weekes C, Spratlin J, Lieu CH, Kane MA, Eppers S, Freas E, Leong S. Phase I trial of vandetanib in combination with gemcitabine and capecitabine in patients with advanced solid tumors with an expanded cohort in pancreatic and biliary cancers. Invest New Drugs. 2016 Apr;34(2):176-83. doi: 10.1007/s10637-015-0316-5. Epub 2015 Dec 30.

  PMID: 26715573 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms

Interventions

Gemcitabine; Capecitabine; vandetanib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stephen Leong, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

US (1)