Study of Temsirolimus, Topotecan, and Bortezomib

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT00770731
• Date of registration: 09/10/2008
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Study of Temsirolimus, Topotecan, and Bortezomib
• Scientific title: A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy
• Date of first enrolment: September 2008
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00770731
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Daniel Karp, MD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with advanced or metastatic cancer that is refractory to standard therapy,
relapsed after standard therapy, or have no standard therapy that improves survival
by at least three months

2. Patients should be at least four weeks or 5 half lives from the last day of
chemotherapy, and antibody or other biological therapy, whichever is shorter.

3. Patients should be at least four weeks from the last day of therapeutic radiation.

4. The Eastern Cooperative Oncology Group (ECOG) performance status >/= 60%.

5. Patients must have allowable organ and marrow function defined as: Absolute
neutrophil count >/= 1,000/mL, Platelets >/=75,000/mL, Serum creatinine Limit of Normal (ULN), Total bilirubin mg/dL.

6. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation, and will be advised to avoid pregnancy for 3
months after completion of therapy.

7. Ability to understand and the willingness to sign a written informed consent
document.

8. Patients may not be receiving any other investigational agents and/or any other
concurrent anticancer agents or therapies except for continuing on hormonal therapy
in cases of prostate cancer.

9. Treatment on this study may begin within 24 hours after Phase 0 dose of temsirolimus.

Exclusion Criteria:

1. Patients with hemoptysis within 28 days prior to entering the study.

2. Patients with clinically significant unexplained bleeding within 28 days prior to
entering the study.

3. Patients with clinically significant cardiovascular disease: • History of CVA within
6 months • Myocardial infarction or unstable angina within 6 months • Unstable angina
pectoris

4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection requiring parenteral antibiotics on Day 1.

5. Pregnant or lactating women.

6. History of hypersensitivity to bortezomib or any component of the bortezomib
formulation.

7. History of hypersensitivity to topotecan or any component of the topotecan
formulation.

8. History of hypersensitivity to temsirolimus or its metabolites (including sirolimus),
polysorbate 80, or to any component of the formulation.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Cancer

Intervention(s)

Drug: Hycamtin (Topotecan)

Drug: Torisel (Temsirolimus)

Drug: Velcade (Bortezomib)

Primary Outcome(s)

Maximum Tolerated Dose (MTD) of combination treatment with temsirolimus, topotecan, and bortezomib [Time Frame: 21 days]

Secondary ID(s)

2008-0425

Source(s) of Monetary Support

Please refer to primary and secondary sponsors