CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma

NCT00634751 | Completed Phase 1 Results DMC

• 6 other identifiers: 2007-0248CO07204H-2007-0248NCI-2011-00475A534260SMPH\MEDICINE\HEM-ONC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combination has been tested in a preliminary trial. We are also testing a survey designed. The purpose of this research study is to investigate the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients report their side effects from chemotherapy treatments.

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms

Keywords

advanced pancreatic and biliary tract carcinomas

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Response rate of participant to treatment

  Up to 18 months

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  Up to 18 months

• Overall Survival

  Up to 18 months

Study Arms (4)

Phase I: 200mg Sorafenib+2DOC

EXPERIMENTAL

Cohort 1: 200mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib

Phase I: 400mg Sorafenib BID+2DOC

EXPERIMENTAL

Cohort 2: 400mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib

Phase II: Pancreatic Cancer

EXPERIMENTAL

Oxaliplatin + Oral Capecitabine + Sorafeni

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib

Phase II: Biliary Tract Cancer

EXPERIMENTAL

Oxaliplatin + Oral Capecitabine + Sorafeni

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib

Interventions

Oxaliplatin DRUG

On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water.

Phase I: 200mg Sorafenib+2DOC; Phase I: 400mg Sorafenib BID+2DOC; Phase II: Biliary Tract Cancer; Phase II: Pancreatic Cancer

Capecitabine DRUG

Each course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis.

Phase I: 200mg Sorafenib+2DOC; Phase I: 400mg Sorafenib BID+2DOC; Phase II: Biliary Tract Cancer; Phase II: Pancreatic Cancer

Sorafenib DRUG

Cohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length Sorafenib 200 mg BID Oral Daily Every 28 days If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd. Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length Sorafenib 400 mg BID Oral Daily Every 28 days

Phase I: 200mg Sorafenib+2DOC; Phase I: 400mg Sorafenib BID+2DOC; Phase II: Biliary Tract Cancer; Phase II: Pancreatic Cancer

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed locally advanced inoperable or metastatic adenocarcinoma of the pancreas or biliary tract who have not previously received more than one systemic treatment for their disease.
• Age at least 18 years old
• ECOG performance status 0-2.
• Patients must have adequate organ and marrow function as defined below:
• WBC at least 3,000
• ANC at least 1,500
• PLT at least 100,000
• total bilirubin must be less than 2.5 x institutional upper limit of norm
• AST(SGOT)/ALT(SGPT) must be less than 5 X institutional upper limit of normal
• creatinine clearance must be greater than 50 mL/min as calculated by the Cockroft-Gault formula
• Patients with ≤ grade 2 (CTC 3.0) neuropathy.
• At least one measurable lesion as defined by RECIST criteria
• The effects of oxaliplatin, capecitabine and sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because DNA alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued if the mother is treated with oxaliplatin.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• No concomitant radiation therapy, or other systemic cancer therapies.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities.
• History of allergy to platinum compounds, capecitabine, sorafenib or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months, symptomatic congestive heart failure, unstable angina pectoris within 3 months prior to entry study, myocardial infarction within 6 months prior to study entry, ongoing cardiac arrhythmia (excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg, despite optimal medical management), pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug, or any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug, serious non-healing wound, ulcer, or bone fracture, evidence or history of bleeding diathesis or coagulopathy.
• Pregnant or nursing women are excluded from this study because oxaliplatin, capecitabine and sorafenib is a DNA alkylating agent with the potential for teratogenic or abortifacient effects. Female patients of reproductive potential must have a negative urine or serum pregnancy test within two weeks prior to enrolling.
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Because of drug interactions with sorafenib, use of St. John's Wort or rifampin (rifampicin) is contraindicated. Patients may discontinue the use of these drugs to become eligible for the study
• Any condition that impairs patient's ability to swallow whole pills.
• HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
• Second malignancy within the past 3 years (excluding nonmelanoma skin cancer and in situ cancers) that has not been treated with curative intent and is not currently without evidence of disease,
• Patients with known gastrointestinal malabsorption syndromes are excluded as this concurrent illness will affect absorption of the oral medications.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Bayer: collaborator
• Sanofi: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms

Interventions

Oxaliplatin; Capecitabine; Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Dr. Noelle LoConte
• Organization: University of Wisconsin Carbone Cancer Center

ns3@medicine.wisc.edu

608-265-5883

Study Officials

• Noelle K LoConte, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 26, 2019
• Results First Posted: August 8, 2017

Record last verified: 2017-07

Locations

US (1)