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Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel

ConditionsPancreatic AdenocarcinomaMetastatic Pancreatic CancerBasal Cell Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.

Age ≥ 18 years at the time of consent.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.

The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.

Disqualifiers

Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1

Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.

Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.

  • Nab paclitaxel

    Drug

    125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.

  • Erlotinib

    Drug

    50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.

  • NALIRIFOX

    Drug

    Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician.

  • Folfirinox

    Drug

    Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: PurIST BasalExperimental treatment 3 interventions
Group B: PurIST ClassicalActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)

Adverse Events (AEs) will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, in Phase I subjects with basal-like settings. The number of participants with adverse events (AE) will be reported. .

Time frame
First day of study treatment through the 28 days after last treatment
2

Dose-limiting toxicity (DLT)

DLTs are defined using adverse events as at least possibly related to erlotinib administration in Phase I subjects. If an apparent DLT is clearly due to an underlying disease and is unrelated to the product infusion, then the investigator will specify that the event is not a DLT. Toxicities related to treatment and assessed Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) will be used for assessment. The safety evaluation period for dose-limiting toxicity (DLT) assessment and determination of optimal best dose (OBD) will encompass toxicities related to treatment with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel starting on the day of treatment initiation through the end of treatment.

Time frame
Up to 28 days
3

Overall survival- classical metastatic pancreatic adenocarcinoma

Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.

Time frame
2 years
4

Progression-free survival

Progression-free survival in subjects on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel with basal-like metastatic pancreatic adenocarcinoma is defined as the length of time between the start of treatment until progression or death.

Time frame
2 years

Secondary outcomes

1

The number of Adverse Events (AEs) in subjects with basal like pancreatic carcinoma

The number of Adverse Events (AEs) in subjects with basal-like pancreatic carcinoma treated with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel as defined by CTCAE v5.

Time frame
First day of study treatment through the 28 days after last treatment
2

Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma

Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel is defined as the length of time from the start of treatment until death (basal-like arm only).

Time frame
2 years
3

The objective response in subjects with classical pancreatic adenocarcinoma

The objective response in subjects with classical pancreatic adenocarcinoma treated with standard-of-care triplet chemotherapy (FOLFIRINOX or NALIRIFOX) as defined as complete response (CR) + partial response (PR) as determined by RECIST 1.1 criteria.

Time frame
Up to 12 weeks
4

The number of Adverse Events (AEs) in subjects with classical pancreatic adenocarcinoma

The number of Adverse Events (AEs) in subjects with classical pancreas carcinoma treated with standard-of-care triplet therapy as defined by CTCAE v5.0.

Time frame
First day of study treatment through the 28 days after last treatment

Other outcomes

Sponsors and contacts

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UNC Lineberger Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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