Chemotherapy for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

+703 other locations

Overseen ByJennifer 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.

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

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

My kidney function tests are within normal limits.

I do not have any serious infections, heart issues, or mental health conditions that would prevent me from following the study's requirements.

I have no allergies to specific cancer drugs like cisplatin or carboplatin.

I haven't had a heart attack, unstable angina, or blood clots in my arteries in the last year.

I do not have problems absorbing medications.

I am not taking Coumadin but may be on other blood thinners.

My cancer is confirmed as non-small cell lung cancer through a biopsy.

I do not have a known DPD deficiency.

My cancer is a type that started in my stomach or pancreas and cannot be surgically removed.

I do not have symptoms from peripheral vascular disease.

I am not pregnant or breast-feeding.

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 can absorb medications properly.

I do not have HIV or take antiretroviral therapy.

I do not have brain metastases or carcinomatous meningitis.

I do not have any active or uncontrolled infections.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (capecitabine, temozolomide)Experimental Treatment3 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 Control4 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 European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Xeloda for: