Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC) (LAPACT)

Celgene

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Drug: nab-Paclitaxel; Drug: Chemoradiation; Drug: Gemcitabine; Procedure: Surgery; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02301143

ABI-007-PANC-007

Details and patient eligibility

About

This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

Full description

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

• No prior anticancer therapy for pancreatic cancer

  •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function

• Signed informed Consent

Exclusion criteria

• Active bacterial, viral, or fungal infection
• Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
• Subjects with sensory neuropathy, ascites, or plastic biliary stent.
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
• Women who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

nab-Paclitaxel plus Gemcitabine

Experimental group

Description:

nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject. * Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR * Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR * Surgical intervention

Treatment:

Procedure: Surgery

Drug: Chemoradiation

Drug: Capecitabine

Drug: Gemcitabine

Drug: nab-Paclitaxel