Purpose

This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

Category

IRB Number
20190915HU
NCT Number
NCT02595424
Open to Enrollment
No
Sponsor
ECOG-ACRIN Cancer Research Group -



Study Contact

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Principal Investigator
Sukeshi Arora

Sukeshi Arora
(210) 450-1015
aroras@uthscsa.edu

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Gastric Neuroendocrine Carcinoma
    2. Intestinal Neuroendocrine Carcinoma
    3. Pancreatic Neuroendocrine Carcinoma

      4. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      Arm B (cisplatin, carboplatin, etoposide)

      		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.
    4. Drug: Carboplatin

      Given IV

    5. Drug: Etoposide

      Given IV

    6. Drug: Cisplatin

      Given IV

    7. Other: Laboratory Biomarker Analysis

      Correlative studies

      8. Experimental

      Arm A (capecitabine, temozolomide)

      		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.
    8. Drug: Temozolomide

      Given PO

    9. Drug: Capecitabine

      Given PO

    10. Other: Laboratory Biomarker Analysis

      Correlative studies

      11.