Vismodegib + Erlotinib (+/- Gemcitabine) for Pancreatic Cancer

This trial tests a combination of cancer drugs to determine the best dose and monitor side effects in patients with metastatic pancreatic cancer or inoperable solid tumors. The drugs under study—Vismodegib (GDC-0449), Erlotinib Hydrochloride, and Gemcitabine Hydrochloride—aim to kill cancer cells or inhibit their growth. Participants must have a type of pancreatic cancer or solid tumor unsuitable for surgery or other standard treatments. This trial targets those who have declined standard treatment or exhausted other options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to receive potentially groundbreaking therapy.

The trial protocol does not specify if you must stop taking your current medications, but it does exclude participants who are currently on a CYP3A4 inhibitor or inducer. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Research has shown that the combination of vismodegib and erlotinib is generally manageable for patients. In earlier studies, patients taking these drugs together often experienced stable cancer for a few treatment cycles, indicating the drugs helped prevent the cancer from worsening temporarily. Although some patients did not see significant changes in their overall condition, most did not experience severe side effects.

Some patients in the study also took gemcitabine, a well-known cancer treatment with established safety. When all three drugs were used together, the combination remained manageable for patients.

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy drugs like gemcitabine, the investigational treatment with Vismodegib and Erlotinib offers a unique mechanism of action. Researchers are excited about these treatments because Vismodegib targets the Hedgehog signaling pathway, which is thought to play a role in the growth of cancer cells. Erlotinib adds another layer by inhibiting EGFR, a protein that helps cancer cells grow and divide. This combination could potentially offer a more comprehensive attack on cancer cells, making it a promising option for patients who may not respond well to existing therapies.

Research has shown that a combination of three drugs—vismodegib, erlotinib, and gemcitabine—might help destroy more cancer cells in pancreatic cancer. In this trial, some participants will receive vismodegib and erlotinib, while others will also receive gemcitabine. Erlotinib blocks certain proteins that cancer cells need to grow. Studies indicate that this drug combination is generally well-tolerated, but it hasn't yet significantly impacted patients with advanced pancreatic cancer. However, some patients have experienced stable disease for several treatment cycles. These early results are promising, but more research is needed to confirm the treatment's effectiveness.¹²³⁴⁶