New cocktail of cancer drugs tested in desperate cases
NCT ID NCT01552434
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested combinations of the drugs bevacizumab and temsirolimus, sometimes with valproic acid or cetuximab, in 154 people with advanced cancers or certain non-cancerous but progressive diseases. The main goal was to find safe doses and look for any signs that the drugs shrink tumors. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab (Avastin) and temsirolimus, alone or with valproic acid or cetuximab
- What this could lead to
- If successful, this could identify safe doses and early signs of tumor shrinkage for these drug combinations in advanced cancers.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not effectiveness. It was terminated, so results may be incomplete. Many drug combinations fail to show benefit in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
154 people
The number who actually took part.
- Started
-
Oct 2012
- Finished
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May 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response of at least 10% or improves survival by at least three months; in addition, patients with disease that are "benign" by pathology, but relentlessly progressive, leading to disability, pain, and premature death in the majority of cases (including, but not limited to lymphangioleiomyomatosis \[LAM\], type 2 neurofibromatosis \[NF\], Erdheim Chester disease, and Castleman's disease) may also be considered for enrollment * Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy; patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Karnofsky \>= 60% * Lansky performance status of \>= 60% for participants 16 years old or younger * Absolute neutrophil count \>= 1,000/mL * Platelets \>= 50,000/mL * Creatinine =\< 3 X upper limit of normal (ULN) * Total bilirubin =\< 3.0 * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 X ULN * Fasting level of total cholesterol of no more than 350 mg/dL * Triglyceride level of no more than 400 mg/dL * 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 * Ability to understand and the willingness to sign a written informed consent document * Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies Exclusion Criteria: * Patients with clinically significant unexplained bleeding within 28 days prior to entering the study * Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg on medication) * Patients with clinically significant cardiovascular disease: History of CVA (cerebrovascular accident) within 6 months, myocardial infarction or unstable angina within 6 months, unstable angina pectoris * Pregnant or breast-feeding women * History of hypersensitivity to bevacizumab, murine products, or any component of the formulation * History of hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation * History of hypersensitivity to cetuximab, murine products, or any component of the formulation * Patients that are taking cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and/or inhibitors; if a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol * Colorectal cancer patients with known v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (for the arm combining bevacizumab, temsirolimus and cetuximab) * Patients who have had major surgery within 6 weeks of enrollment in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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