Predicting Effective Therapy in Pancreatic Cancer

Active, not recruiting

• Conditions: Pancreatic Adenocarcinoma; Pancreatic Cancer
• Interventions: Diagnostic Test: CTC isolocation and analysis

• Registration Number: NCT03033927
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-24
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-01-24
• Study Completion: 2025-01-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
• Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
• Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
• ECOG performance status 0-2.
• A minimum age of 18 years old.

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Exclusion Criteria

• Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
• Known to be HIV positive on antiretroviral therapy
• Prior organ allograft
• Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Stage IV Pancreatic Cancer	CTC isolocation and analysis	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	36 months	in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis

Trial Locations

Locations (4)

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States