Molecularly Tailored Therapy for Pancreas Cancer

Georgetown University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gem-Tax; Drug: FOLFIRI; Drug: Ox-Tax; Drug: Gem-OX; Drug: Gem-5FU; Drug: Tax-Iri; Drug: Modified FOLFOX-6

Study type: Interventional

Funder types: Other

Identifiers

NCT01888978

2011-384

Details and patient eligibility

About

Patient therapy is tailored according to the molecular profile of the patient's tumor.

Full description

This study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to determine whether molecularly tailored therapy can improve the effectiveness of standard chemotherapy combinations for patients with metastatic pancreatic cancer. A series of special tests will be performed on a sample of tumor, and based on the results subjects will be assigned to one of seven chemotherapy treatments, with each being the combination of two standard chemotherapies. Each of these combinations has been safely used in patients with pancreatic or other types of cancer. The purpose of this study is to to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. A second purpose is not to determine if one doublet is better than another. Rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven pancreatic adenocarcinoma with measurable disease
• Biopsy accessible tumor deposits
• ECOG performance status 0-2
• Age >/= 18 years
• Subjects with no brain metastases or history of previously treated brain metastases
• Adequate hepatic, renal, and bone marrow function
• Partial thromboplastin time must be </= 1.5 x upper normal limit of institution's normal range and INR < 1.5
• Life expectancy > 12 weeks
• Women of childbearing potential must have a negative seum pregnancy test within 14 days prior to initiation of treatment
• Subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the consents

Exclusion criteria

• CNS metastases which do not meet criteria outlines in inclusion criteria
• Active severe infection or known chronic infection with HIV or hepatitis B virus
• Cardiovascular disease
• Life threatening visceral disease or other severe concurrent disease
• Women who are pregnant, breastfeeding, or women of childbearing potential not using dual forms of effective contraception
• Anticipated patient survival under 3 months
• Patients receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, oxaliplatin, 5-FU, docetaxel or irinotecan
• Uncontrolled intercurrent illness

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 7 patient groups

Modified FOLFOX-6

Experimental group

Description:

Oxaliplatin 85 mg/m2 day 1 and 5-fluorouracil 400 mg/m2 day 1 and Leucovorin 400 mg/m2 day 1 and 5-fluorouracil 2400 mg/m2 over 46 hours on day 1-3 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: Modified FOLFOX-6

Ox-Tax

Experimental group

Description:

Docetaxel 65 mg/m2 and Oxaliplatin 100 mg/m2 on day 1 every 3 weeks All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: Ox-Tax

FOLFIRI

Experimental group

Description:

Irinotecan 180 mg/m2 on day 1 and 5-FU 400 mg/m2 on day 1 and Leucovorin 400 mg/m2 day 1 and 5-FU 2400 mg/m2 over 46 hours, days 1-3 as a continuous infusion All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: FOLFIRI

Tax-Iri

Experimental group

Description:

2 weeks on, 1 week off of Docetaxel 35 mg/m2/week and Irinotecan 50 mg/m2/week Both administered on day 1 of each week of treatment All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: Tax-Iri

Gem-Ox

Experimental group

Description:

Gemcitabine: 1000 mg/m2 over 100 minutes on Day 1 Oxaliplatin: 100 mg/m2 over 120 minutes on Day 2 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: Gem-OX

Gem-5FU

Experimental group

Description:

Gemcitabine: 1000 mg/m2 over 30 minutes 5-FU 2000/m6 as a 24 hour infusion on days 1, 8, and 15 of every 28 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed

Treatment:

Drug: Gem-5FU

Gem-Tax

Experimental group

Description:

Gemcitabine 1000 mg/m2 over 30 minutes and Docetaxel 35 mg/m2 over 60 minutes on days 1, 8, and 15 of every 28 day cycle

Treatment:

Drug: Gem-Tax