Chemotherapy for Neuroendocrine Cancer

Recruiting at703 trial locations

Overseen by Jennifer Eads

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing two different sets of cancer drugs to see which works better for patients with advanced neuroendocrine carcinoma that has spread or cannot be removed by surgery. The drugs aim to stop cancer from growing and spreading by attacking the cancer cells in different ways. One of the drugs being tested is used for treating advanced neuroendocrine tumors.

Research Team

Jennifer Eads

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with advanced, inoperable or metastatic neuroendocrine carcinoma of the gastrointestinal tract or pancreas. They should not have had prior systemic treatment for this cancer and must be physically well enough to participate (ECOG 0-2). Participants need functioning major organs, no severe allergies to study drugs, no other cancers unless specific conditions are met, and cannot be pregnant. Effective contraception is advised.

Inclusion Criteria

The cells in your sample show rapid growth, or there are a lot of dividing cells in the sample.

My cancer's size can be measured and was checked by CT or MRI within the last 4 weeks.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I am allergic to certain chemotherapy drugs like cisplatin or carboplatin.

I do not have serious heart issues, unstable chest pain, irregular heartbeats, or major psychiatric/social situations that would prevent me from following the study's requirements.

I have no other cancers, except for certain allowed types.

Treatment Details

Interventions

• Capecitabine (Anti-metabolites)
• Carboplatin (Alkylating agents)
• Cisplatin (Alkylating agents)
• Etoposide (Topoisomerase I inhibitors)
• Temozolomide (Anti-metabolites)

Trial Overview The trial compares two chemotherapy regimens: temozolomide plus capecitabine versus cisplatin or carboplatin with etoposide. It aims to determine which combination is more effective against certain types of neuroendocrine carcinomas that haven't responded well to standard treatments.

Participant Groups

Group I: Arm A (capecitabine, temozolomide) Experimental Treatment 3 Interventions

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cisplatin, carboplatin, etoposide) Active Control 4 Interventions

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Dr. Peter J. O'Dwyer

ECOG-ACRIN Cancer Research Group

Chief Executive Officer since 2012

MD from University of Pennsylvania

Dr. Mitchell D. Schnall

ECOG-ACRIN Cancer Research Group

Chief Medical Officer since 2012

MD, PhD from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School