Nab-Paclitaxel + Bevacizumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byMatthew S. Block, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor cells than nab-paclitaxel alone.

Research Team

Matthew S. Block, M.D., Ph.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults with stage IV melanoma or gynecological cancers that can't be surgically removed. Participants must have had 1-4 prior chemotherapy treatments, including a taxane and platinum agent, and be resistant to platinum if they've had 1-2 chemo lines. They should not have received certain therapies recently and must not have other severe diseases or conditions that could affect the study.

Inclusion Criteria

You are expected to live for at least 3 months.

You are okay with giving blood samples for research purposes.

My cancer returned or worsened within 6 months after my last platinum-based chemotherapy.

See 35 more

Exclusion Criteria

I am currently being treated for inflammatory bowel disease.

I have not had diverticulitis or pancreatitis in the last 6 months.

You have had brain metastases shown on an MRI or CT scan before.

See 15 more

Treatment Details

Interventions

Bevacizumab (Angiogenesis Inhibitor)
Nab-paclitaxel (Mitotic Inhibitor)

Trial OverviewThe trial tests nab-paclitaxel combined with bevacizumab versus nab-paclitaxel alone in patients with advanced melanoma or gynecological cancers. It aims to find the safest doses and see if adding bevacizumab improves outcomes by inhibiting blood vessel growth necessary for tumor survival.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (AB-complex)Experimental Treatment4 Interventions

Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

Bevacizumab is already approved in Japan, Canada for the following indications: