Adenocarcinoma Clinical Trial
Official title:
PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma
Verified date | March 2021 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 20, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma 2. Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery - >6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy) - No prior treatment with any targeted agent - Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening. 3. Measurable metastatic disease by RECIST criteria, - Must be amenable to ultrasound or CT-guided biopsy of one metastatic lesion - Peritoneal disease as the sole site of occult metastasis or presenting as malignant ascites is acceptable if a cell block of tumor cells can be obtained showing >20% viable tumor cells. 4. ECOG PS 0,1 5. Age > 18 years 6. Patients must have normal organ and marrow function as defined below: - granulocytes >1,2500/mcL - platelets >100,000/mcL - total bilirubin < 1.5 x ULN, <1.8 x ULN with liver metastases - AST(SGOT)/ALT(SGPT) <2.5 X ULN without liver metastases; <5 X ULN with liver metastases - creatinine within normal institutional limits (<1.5) OR - creatinine clearance >50 mL/min/1.73m2, (for creatinine level above normal) - INR: < 1.5 (patients on warfarin need to be converted to LMWH during study participation to be eligible) 7. Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative studies. • Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies 8. Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed PANGEA treatment with first, second and third line therapy as tolerated. 9. Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form. 10. If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than: Epirubicin < 720 mg/m2 Doxorubicin or liposomal doxorubicin < 360 mg/m2 Mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 If more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin. 11. Cardiac Ejection Fraction >50% (for HER2+ patients) as assessed by echocardiogram, MUGA scan, or cardiac MRI 12. Willingness to use effective and reliable methods of contraception (For appropriate methods of contraception considered acceptable see Appendix B). Both men and women and members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: 1. No CVA within 6 months, no recent MI within 6 months 2. No currently active second malignancy 3. No uncontrolled intercurrent illness or infection 4. No peripheral edema > grade 2 at baseline. 5. No peripheral neuropathy > grade 2 at baseline. 6. No diarrhea > grade 2 at baseline. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | AbbVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | First-line Progression-free Survival | Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Up to 60 Months | |
Other | Objective Response to First Line Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 6 months | |
Primary | Overall Survival | Time from enrollment to death from any cause. | Up to 60 months | |
Secondary | Number of Biopsies Leading to an Adverse Event | Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis). | 1 Month | |
Secondary | Completion of Biopsy and Successful, Molecularly-based Treatment Assignment | Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Up to 1 month | |
Secondary | Adverse Event From Serial Biopsy for Second-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | Up to 60 Months | |
Secondary | Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Up to 60 months | |
Secondary | Adverse Event From Serial Biopsy for Third-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | Up to 60 months | |
Secondary | Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Up to 60 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Withdrawn |
NCT05325164 -
Methadone for 'Adenocarcinopathic' Pain Treatment
|
Phase 3 | |
Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT02125240 -
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
|
Phase 3 | |
Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
Completed |
NCT02454647 -
Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
|
N/A | |
Completed |
NCT01579721 -
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
|
Phase 4 | |
Withdrawn |
NCT01148082 -
School Response to Families Who Have Children With Cancer
|
N/A | |
Completed |
NCT01206530 -
FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00548548 -
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
|
Phase 3 | |
Completed |
NCT00377936 -
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
|
Phase 2 | |
Completed |
NCT00129844 -
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00183859 -
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
|
Phase 1 | |
Recruiting |
NCT01930864 -
Metformin Plus Irinotecan for Refractory Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02498860 -
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
|
Phase 2 | |
Terminated |
NCT01441128 -
-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04400474 -
Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
|
Phase 2 | |
Recruiting |
NCT02133196 -
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
|
Phase 2 |