Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery

Part of paid clinical trials in Corona, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03008278
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Esophageal Carcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Recurrent Esophageal Carcinoma
  • Recurrent Gastric Carcinoma
  • Recurrent Gastroesophageal Junction Adenocarcinoma
  • Stage III Esophageal Cancer AJCC v7
  • Stage III Gastric Cancer AJCC v7
  • Stage IV Esophageal Cancer AJCC v7
  • Stage IV Gastric Cancer AJCC v7
  • Unresectable Esophageal Carcinoma
  • Unresectable Gastric Carcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Give PO
  • Ramucirumab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be removed by surgery (unresectable). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer compared to ramucirumab and paclitaxel (a chemotherapy drug) or ramucirumab alone.

Key Dates

Start date
Feb 6, 2018
Status verified
Jan 2026
Primary completion
Jun 30, 2023
Completion
Aug 13, 2025

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib, ramucirumab)
    Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I) [ Time Frame: Up to 28 days ]

Locations (32)

FacilityCityStateZIPSite coordinators
City of Hope CoronaCoronaCalifornia92882-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope UplandUplandCalifornia91786-
Smilow Cancer Hospital-Derby Care CenterDerbyConnecticut06418-
Smilow Cancer Hospital Care Center-FairfieldFairfieldConnecticut06824-
Smilow Cancer Hospital Care Center - GuilfordGuilfordConnecticut06437-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Yale-New Haven Hospital North Haven Medical CenterNorth HavenConnecticut06473-
Smilow Cancer Hospital-Orange Care CenterOrangeConnecticut06477-
Smilow Cancer Hospital-Torrington Care CenterTorringtonConnecticut06790-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
Smilow Cancer Hospital-Waterbury Care CenterWaterburyConnecticut06708-
Smilow Cancer Hospital Care Center - WaterfordWaterfordConnecticut06385-
University of Florida Health Science Center - GainesvilleGainesvilleFlorida32610-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Corona, CA

By research site
City of Hope Corona· Corona, CACity of Hope Comprehensive Cancer Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCSF Medical Center-Mount Zion· San Francisco, CACity of Hope South Pasadena· South Pasadena, CA

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