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Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors

Phase 1
18 Years
Open (Enrolling)
Metastatic Breast Cancer, Gastrointestinal Tumors

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Trial Information

Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors

This is a pilot study of Sorafenib combined with Capecitabine in patients with
histologically confirmed unresectable or metastatic breast and GI tumors. One cycle will
consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally
daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7
days every 14 days

Inclusion Criteria:

- Age ≥ 18 years.

- Life expectancy of at least 12 weeks (3 months).

- ECOG Performance Status 0 or 1.

- Histologically confirmed unresectable or metastatic breast and/or GI tumors for which
curative standard treatments are unavailable

- Adequate bone marrow, liver and renal function as assessed by the following:

- Hemoglobin > 9.0 g/dl

- Absolute neutrophil count (ANC) >1,500/mm3

- Platelet count > 100,000/mm3

- Total bilirubin < 1.5 times ULN

- ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)

- GFR > 30 ml/min

- All acute toxic effects (excluding alopecia and neuropathy) of any prior treatment
have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed
Consent Form (ICF).

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of study drug. Post-menopausal women (defined as no
menses for at least 1 year) and surgically sterilized women are not required to
undergo a pregnancy test.

- Subjects (men and women) of childbearing potential must agree to use adequate
contraception beginning at the signing of the ICF until at least 30 days after the
last dose of study drug. The definition of adequate contraception will be based on
the judgment of the principal investigator or a designated associate.

- Subject must be able to swallow and retain oral medication.

- Subjects must be able to understand and be willing to sign the written informed
consent form. A signed informed consent form must be appropriately obtained prior to
the conduct of any trial-specific procedure.

Exclusion Criteria:

- Metastatic brain or meningeal tumors (unless subject completed definitive therapy
more than 1 month previously and is stable off steroids).

- Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.

- Active or clinically significant cardiac disease including:

- Congestive heart failure - New York Heart Association (NYHA) > Class II.

- Active coronary artery disease.

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
or digoxin.

- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months
before randomization, or myocardial infarction within 6 months before

- Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or
higher within 4 weeks of study enrollment; any other hemorrhage/bleeding event of
NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks of study enrollment.

- Major surgery, open biopsy or significant traumatic injury within 30 days of first
study drug.

- Presence of an active non-healing wound, non-healing ulcer, or bone fracture.

- Thrombotic or embolic events such as a cerebrovascular accident (including transient
ischemic attacks) within 3 month of informed consent.

- Anticoagulation with warfarin is not permitted.

- Evidence or history of bleeding diathesis or coagulopathy.

- Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine,
phenobarbital, St. John's Wort [Hypericum perforatum], dexamethasone at a dose of
greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) within 30 days
of trial enrollment.

- Subjects with a history of dihydopyrimidine dehydrogenase (DHPD) deficiency or severe
and unexpected reactions to fluropyrimidines.

- Subjects with any previously untreated or concurrent cancer that is distinct in
primary site or histology except cervical cancer in-situ, treated basal cell
carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was
curatively treated and without evidence of disease for more than 3 years before
randomization are allowed. All relevant cancer treatments must be completed at least
3 years prior to study entry (i.e., signature date of the informed consent form).

- History of organ allograft. (Including corneal transplant).

- Known human immunodeficiency virus (HIV) infection or Hepatitis B or C currently
undergoing active antiviral treatment.

- Any malabsorption problem.

- Anticancer chemotherapy or immunotherapy during the study is not permitted.

- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug
classes, or excipients of the formulations given during the course of this trial.

- Women who are pregnant or breast-feeding.

- Inability to comply with the protocol and/or not willing or not available for
follow-up assessments.

- Any condition which, in the investigator's opinion, makes the subject unsuitable for
trial participation.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose / Safety

Outcome Description:

Primary Objectives: Safety Determination of maximum tolerated dose

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Gina Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Gastrointestinal Tumors
  • histologically
  • unresectable
  • metastatic
  • Phase 1
  • Breast Cancer
  • GI Tumors
  • Sorafenib
  • Capecitabine
  • Breast Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms



Yale Cancer CenterNew Haven, Connecticut  06520-8028