Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT04660760
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Unresectable Gastric Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Complete questionnaires
  • Ramucirumab — BIOLOGICAL
    Given IV
  • Trifluridine and Tipiracil Hydrochloride — DRUG
    Given PO

Study Details

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.

Key Dates

First listed
Dec 9, 2020
Start date
Jun 16, 2021
Status verified
May 2023
Primary completion
Jul 31, 2024
Completion
May 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (TAS-102, ramucirumab)
    Patients receive TAS-102 PO BID on days 1-5 and 8-12, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm B (paclitaxel, ramucirumab)
    Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival [ Time Frame: Up to 1 year ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233
Darryl A. Outlaw
[email protected]
Darryl A. Outlaw (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in ArizonaScottsdaleArizona85259
ACCRU Operations
[email protected]
507-538-7448
Mohamad B. Sonbol (PRINCIPAL_INVESTIGATOR)
Arizona Clinical Research CenterTucsonArizona85715-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
ACCRU Operations
[email protected]
507-538-7448
Syma Iqbal (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
ACCRU Operations
[email protected]
507-538-7448
Jason S. Starr (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic-WestonWestonFlorida33331
ACCRU Operations
[email protected]
507-538-7448
Arun Nagarajan (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Carle Cancer Center NCI Community Oncology Research ProgramUrbanaIllinois61801-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242
ACCRU Operations
[email protected]
507-538-7448
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
Cancer Center of Kansas - WichitaWichitaKansas67214-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
University of Nebraska Medical CenterOmahaNebraska68198-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Clinical Trial Information Program
[email protected]
800-811-8480
Michael Gibson (PRINCIPAL_INVESTIGATOR)
Saint Vincent Hospital Cancer Center Green BayGreen BayWisconsin54301
ACCRU Operations
[email protected]
507-538-7448
Anthony J. Jaslowski (PRINCIPAL_INVESTIGATOR)
Aurora Cancer Care-Milwaukee WestWauwatosaWisconsin53226-

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University of Alabama at Birmingham Cancer Center· Birmingham, ALMayo Clinic in Arizona· Scottsdale, AZArizona Clinical Research Center· Tucson, AZUSC / Norris Comprehensive Cancer Center· Los Angeles, CAMayo Clinic in Florida· Jacksonville, FLCleveland Clinic-Weston· Weston, FL

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