Research Study for Advanced or Metastatic Colon or Rectal Cancer

Name of Study: A phase I/II/pharmacodynamic study of hydroxychloroquine in combination with FOLFOX plus bevacizumab to inhibit autophagy in colorectal cancer

Who is eligible?

• Diagnosed with advanced or metastatic colon or rectal cancer (cancer that has spread to other parts of the body).
• If previously treated with chemotherapy after surgery (adjuvant therapy), must be at least 6 months since last dose of chemotherapy.
• Cannot have previously received bevacizumab (Avastin).

How this study is different from other standard therapies for colon cancer

We are testing the ability of a small molecule to overcome resistance (a process called autophagy) to the tumor. Chemotherapy resistance occurs when cancers that have been responding to a therapy suddenly begin to grow. In other words, the cancer cells are resisting the effects of the chemotherapy.

About the study

Participants will:

• Receive standard of care treatment for colorectal cancer including a combination of drugs: 5-­fluorouracil, leucovorin, oxaliplatin (FOLFOX) and bevacizumab (also known as Avastin).
• The addition of a drug called hydroxychloroquine (HCQ) to the standard regimen for advanced colorectal cancer.

About HCQ:

• HCQ may be effective in helping the standard therapy to work by preventing cancer cells from becoming resistant and growing
• HCQ is approved by the FDA for the treatment of malaria and rheumatoid arthritis and has been combined safely with other chemotherapy drugs.

For more information about this trial

• Visit clinicaltrials.gov.
• For study related questions, call Maryanne Redlinger, Clinical Research Nurse Coordinator 215 662 7452.
• To make an appointment with a Penn Medical Oncologist who can tell you about this and other trials, as well as treatment for colon cancer call 1-800-789-PENN (7366).