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Combining Abraxane With Capecitabine and Radiation Therapy for Consolidation of Treatment Following Induction Chemotherapy for Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02394535
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of Abraxane™ (nab-paclitaxel) that can be given in combination with capecitabine and radiation therapy to patients with pancreatic cancer. The safety of this drug and drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Abraxane Drug: Capecitabine Radiation: Radiation Therapy Behavioral: Questionnaires Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combining Abraxane With Capecitabine and Radiation Therapy for Consolidation of Treatment Following Induction Chemotherapy for Locally Advanced Pancreatic Cancer
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abraxane (Nab-Paclitaxel) + Capecitabine + Radiation Therapy

Phase I study and a standard 3+3 design used to determine maximum tolerated dose (MTD) dose of Abraxane with Radiation Therapy and Capecitabine. Up to 3 dose levels of Abraxane tested. First group of participants receive lowest dose level. Each new group receives a higher dose than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Abraxane is found. Once MTD identified an expansion cohort of 12 patients enrolled.

Starting dose of Abraxane 50 mg/m2 by vein weekly Day 1, 8, 15, 22 and 29. Capecitabine 825 mg/m2 by mouth twice a day only on days of radiation. Radiation Therapy delivered at a dose of 50.4 Gy in 1.8 Gy fractions 1 time each day on Monday through Friday for 5½ weeks.

Symptom and Quality of Life (QOL) Questionnaire completed at baseline, and 4 - 6 weeks after radiation therapy.

Drug: Abraxane

Dose Escalation Starting dose of Abraxane: 50 mg/m2 by vein weekly Day 1, 8, 15, 22 and 29.

Dose Expansion Starting Dose of Abraxane: MTD dose from Dose Escalation.

Other Names:
  • Nab-Paclitaxel
  • Paclitaxel (Protein-Bound)
  • ABI-007

Drug: Capecitabine
Dose Escalation and Dose Expansion Dose of Capecitabine: 825 mg/m2 by mouth twice a day only on days of radiation.
Other Name: Xeloda

Radiation: Radiation Therapy
Radiation Therapy delivered at a dose of 50.4 Gy in 1.8 Gy fractions, 1 time each day on Monday through Friday for 5½ weeks.
Other Name: XRT

Behavioral: Questionnaires
Symptom and Quality of Life (QOL) Questionnaire completed at baseline, and 4 - 6 weeks after radiation therapy.
Other Name: Surveys




Primary Outcome Measures :
  1. Maximum Tolerated Dose of Abraxane with Capecitabine and Radiation Therapy [ Time Frame: 4 weeks ]
    MTD defined as the highest dose level in which 6 patients have been treated with at most 1 instance of dose limiting toxicity (DLT). DLT defined as any non-hematologic adverse events of grade 3 or greater (CTCAE version 4) that occurs during the first 4 weeks of the combination therapy.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 3 months ]

    Complete response (CR) — complete disappearance of clinical evidence of a tumor. Radiographically equivocal lesions must remain stable or regress.

    Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline.

    Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%.

    Progressive disease (PD) — a 25% increase in area of a lesion >2 cm2 or a 50% increase in size if area of lesion was 2 cm2. Appearance of new lesions constitutes progressive disease. Comparisons of tumor size made with previous smallest measurement in participants who have attained a partial response or with baseline measurements in participants with stable disease. Tumor progression also defined as significant clinical deterioration that cannot be attributed to treatment or other medical conditions.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ECOG performance status of 0 or 1
  2. Patients must be > 18 years of age. There will be no upper age restriction.
  3. Cytologic or histologic proof of adenocarcinoma of the pancreas. Patients can have tumor which is locally advanced or borderline resectable. Unequivocal metastases and Islet cell tumors are not eligible.
  4. All patients must be staged with a physical exam, CT of the chest and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence.
  5. Patients must have received prior induction chemotherapy for at least 2 months and up to 8 months. At least three weeks should have elapsed after the last chemotherapy.
  6. Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL and ANC >/= 1,500 cells/mm3.
  7. Hepatic function: Bilirubin </= 1.5 mg/dL. Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal.
  8. Renal function: BUN < 30 mg/dL, creatinine </=1.5 mg/dL or creatinine clearance > 30ml/min (estimated as calculated with Cockcroft-Gault equation).
  9. Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
  10. Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
  11. Patients must have recovery from other clinically significant, non-hematologic toxicities to </= Grade 2.
  12. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
  13. Negative serum or urine beta-hCG pregnancy test at screening for female patients of childbearing potential.

Exclusion Criteria:

  1. Prior abdominal radiotherapy
  2. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
  3. Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapy.
  4. Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
  5. Prior history of cancer within the last three years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with previous malignancies but without evidence of disease for 3 years will be allowed to enter the trial.
  6. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
  7. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to swallow.
  8. Known, existing uncontrolled coagulopathy, INR > 1.5.
  9. Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed. Intravenous and low-molecular weight heparin are permitted.
  10. Patients taking Sorivudine or Brivudine must be off of these drugs for 4 weeks prior to starting capecitabine. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it.
  11. Inability to comply with study and/or follow-up procedures
  12. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394535


Contacts
Contact: Sunil Krishnan, MD 713-563-2300

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Sunil Krishnan, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02394535     History of Changes
Other Study ID Numbers: 2014-0469
NCI-2015-00516 ( Registry Identifier: NCI CTRP )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Adenocarcinoma of the pancreas
Locally Advanced Pancreatic Cancer
Abraxane
Nab-Paclitaxel
Paclitaxel (Protein-Bound)
ABI-007
Radiation therapy
XRT
Capecitabine
Xeloda
Questionnaires
Surveys

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites