Avastin/Torisel With Carboplatin, Taxol, or Sorafenib

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01187199
First received: August 20, 2010
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations will also be studied.


Condition Intervention Phase
Advanced Cancer
Drug: Temsirolimus
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Sorafenib
Drug: Carboplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
    MTD defined by dose-limiting toxicities (DLTs) that occur during the first four weeks of therapy.


Estimated Enrollment: 278
Study Start Date: August 2010
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin Group
Carboplatin: Starting dose AUC 2 by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Drug: Temsirolimus
Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
Other Names:
  • CCI-779
  • Torisel
Drug: Bevacizumab
Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Carboplatin
Starting dose AUC 2 by vein on day 1 of a 21 day cycle.
Other Name: Paraplatin
Experimental: Paclitaxel Group
Paclitaxel: Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Drug: Temsirolimus
Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
Other Names:
  • CCI-779
  • Torisel
Drug: Bevacizumab
Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Paclitaxel
Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle.
Other Name: Taxol
Experimental: Sorafenib Group
Sorafenib: Starting dose 200 mg by mouth daily for a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Drug: Temsirolimus
Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
Other Names:
  • CCI-779
  • Torisel
Drug: Bevacizumab
Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Sorafenib
Starting dose 200 mg by mouth daily for a 21 day cycle.
Other Names:
  • Nexavar
  • BAY 43-9006

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Inclusion: (For all treatment arms)
  2. 1.1 Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  3. 1.2 Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation does not target the only measurable or evaluable disease.
  4. 1.3 Patients must have measurable or evaluable disease
  5. 1.4 ECOG performance status </= 2 (Karnofsky >/= 60%, Lansky >/= 50%).
  6. 1.5 Patients must have normal organ function defined as: creatinine </= 1.5 x ULN for children and </= 2.0 x ULN for adults; total bilirubin </= 2.0; ALT(SGPT)/AST (SGOT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT/AST may be elevated as high as 8 X ULN.
  7. 1.6 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, for the duration of study participation, and for 90 days after the last dose.
  8. 1.7 Ability to understand and the willingness to sign a written informed consent document.
  9. 1.8 Life expectancy of at least 3 months.
  10. 1.9 Patients may not be receiving any other experimental agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance.
  11. Inclusion: (For carboplatin and paclitaxel arms)
  12. 2.1 Patients must have normal marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/= 100,000/mL.
  13. 2.2 Patient with neuropathies of CTC grade 1 or less.
  14. Inclusion: (For sorafenib arm)
  15. 3.1 Patients must have normal marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/= 75,000/mL.

Exclusion Criteria:

  1. Exclusion: (For all treatment arms)
  2. 4.1 Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
  3. 4.2 Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
  4. 4.3 Patients with clinically significant cardiovascular disease: History of CVA within 6 months Myocardial infarction or unstable angina within 6 months Unstable angina pectoris New York Heart Association Class > II
  5. 4.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
  6. 4.5 Pregnant or lactating women.
  7. 4.6 History of hypersensitivity to bevacizumab or murine products, temsirolimus or its metabolites, or any component of the formulation.
  8. 4.7 Patients with hemorrhagic brain metastases.
  9. 4.8 Patients with prior abdominal surgery within 30 days prior to entering the study.
  10. 4.9 Medications with potent inducer or inhibitor of P450 3A4 should be avoided within 5 half lives of temsirolimus.
  11. Exclusion: (For carboplatin treatment arm)
  12. 5.1 Hypersensitivity to carboplatin or any component of the formulation.
  13. Exclusion: (For paclitaxel treatment arm)
  14. 6.1 Hypersensitivity to paclitaxel or any component of the formulation.
  15. Exclusion: (For sorafenib treatment arm)
  16. 7.1 History of hypersensitivity to sorafenib or any component of the formulation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187199

Contacts
Contact: Shannon Westin, MD 713-563-1930

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Shannon Westin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01187199     History of Changes
Other Study ID Numbers: 2010-0486, NCI-2012-01788
Study First Received: August 20, 2010
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Metastatic cancer
Chemotherapy
Avastin
Carboplatin
Paclitaxel
Sorafenib
Temsirolimus

Additional relevant MeSH terms:
Neoplasms
Bevacizumab
Carboplatin
Everolimus
Paclitaxel
Sirolimus
Sorafenib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014