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Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)

Phase 1
70 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Sarcoma

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Trial Information

Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)



- To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in
treating elderly patients with advanced solid tumors.


- To characterize the quantitative and qualitative toxicities of bortezomib and
gemcitabine in these patients.

- To obtain preliminary information about the anti-tumor activity of bortezomib and

- To characterize gemcitabine and metabolite pharmacokinetics in patients receiving
concurrent bortezomib therapy.

OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine.

Patients receive gemcitabine intravenously (IV) over 30 minutes followed 1 hour later by
bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the
maximum tolerated dose of the combination is determined.

Blood is collected periodically for pharmacokinetic and pharmacogenetic studies.

After completion of study treatment, patients are followed every 3 months for up to 1 year.

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced non-hematologic
malignancy, including any of the following:

- Breast cancer

- Lung cancer

- Colon cancer

- Pancreatic cancer

- Head and neck cancer

- Sarcoma

- Must have failed or become intolerant to prior standard therapy and is no longer
likely to respond to such therapy (for all diseases except pancreatic cancer)

- Pancreatic cancer patients may be enrolled with no prior therapy requirements
since gemcitabine is the current standard of care 1st line therapy

- Measurable or nonmeasurable disease

- Concurrent enrollment in the University of Minnesota study "Population
Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid
Tumors" (Human Subjects Code 0508M72989) required

- ECOG performance status of 0-1

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN
(5 times ULN if liver has tumor involvement)

- Calculated or measured creatinine clearance > 30 mL/minute

- Fertile patients must use effective contraception during and for 3 months after study

- Recovered from all prior therapy

- Prior systemic chemotherapy, immunotherapy, or biological therapy allowed

- At least 3 months since prior bortezomib and/or gemcitabine

- At least 2 weeks since prior systemic therapy

- At least 3 weeks since prior investigational agents (for reasons other than the
treatment of cancer)

- At least 2 weeks since prior radiotherapy

Exclusion Criteria:

- Symptomatic brain metastases

- Serious concomitant medical or psychiatric disorders (e.g., active infection or
uncontrolled diabetes) that, in the opinion of the investigator, would compromise the
safety of the patient or compromise the patient's ability to complete the study

- Myocardial infarction within the past 6 months

- New York Heart Association (NYHA) Class III or IV heart failure

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias

- Electrocardiographic evidence of acute ischemia or active conduction system

- Peripheral neuropathy ≥ grade 2

- Known hypersensitivity to bortezomib, boron or mannitol

- Prior radiotherapy to ≥ 25% of the bone marrow

- Prior radiotherapy to the whole pelvis

- Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study

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 of bortezomib and gemcitabine

Outcome Description:

A minimum of a 3 week period (1 cycle) must be completed by all patients within a dose level before dose escalation to the next level may occur. A cycle is defined as treatment day 1 and 8 with follow-up through day 21.

Outcome Time Frame:

Day 21 (Week 3 - Cycle 1)

Safety Issue:


Principal Investigator

Arkadiusz Dudek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Sarcoma
  • recurrent pancreatic cancer
  • recurrent breast cancer
  • recurrent small cell lung cancer
  • recurrent non-small cell lung cancer
  • recurrent colon cancer
  • recurrent prostate cancer
  • recurrent head and neck cancer
  • ovarian cancer
  • recurrent uterine cancer
  • recurrent kidney cancer
  • recurrent osteosarcoma
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Sarcoma



Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455