A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer

NCT00553813 | Terminated Phase 2

• 1 other identifier: TPI 287-06
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 4

Brief Summary

The primary objective of the study is to assess the activity of TPI 287 as single agent therapy for patients with advanced, unresectable pancreatic cancer after failure of gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month survival rate.

Conditions

Pancreatic Cancer

Keywords

Unresectable; Gemcitabine; Taxane; TPI 287

Outcome Measures

Primary Outcomes (1)

• Survival

  6 Months

Secondary Outcomes (6)

• Overall Response Rate

  Ongoing

• Evaluate time to worsening of clinical status as measured by changes in pain, Karnofsky score, and weight.

  Ongoing

• Response rates and time to progression of tumor marker levels (CA 19-9)

  Ongoing

• Assess the safety and tolerability of TPI 287 in this patient population

  Ongoing

• Evaluate outcomes of patient subsets defined by duration of prior gemcitabine therapy

  Ongoing

Interventions

TPI 287 DRUG

Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histological or cytological confirmation of ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
• Patients must have metastatic disease precluding curative surgery
• Patients must have received only one prior systemic anticancer treatment for their advanced disease, which must have included a gemcitabine-based therapeutic regimen for advanced disease
• Patients may have received prior adjuvant therapy for their disease
• Patients must have a Karnofsky performance status ≥ 70 (Appendix I)
• Patients must be ≥ 18 years of age
• Women of childbearing potential (WOCBP):
• Must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study
• Must have a negative serum or urine pregnancy test
• Patients must have adequate organ function:
• Bone marrow reserve as evidenced by: Absolute neutrophil count ≥1,500/uL, Platelet count ≥ 100,000/uL
• Renal function as evidenced by serum creatinine ≥ 2.0 mg/uL
• Hepatic function as evidenced by: Serum total bilirubin \< 2.0 mg/uL, SGOT/SGPT \< 3X ULN for the reference lab (\< 5X ULN for patients with known hepatic metastases)
• Patient must have recovered from prior surgery, radiotherapy or other antineoplastic therapy
• Patients or their legal representative must be able to read, understand, and sign the informed consent to participate in the trial

You may not qualify if:

• Patients with islet cell tumors, lymphoma, or sarcoma of the pancreas
• Patients with more than one prior treatment for metastatic pancreatic carcinoma
• Patients with current peripheral neuropathy \> Grade 1
• Patients receiving any concurrent chemotherapy, radiotherapy, hormonal therapy or immunotherapy
• Patients with serious infection or a life-threatening illness (unrelated to tumor) that is \> Grade 2 NCI CTCAE V 3.0), or active, serious infections requiring parental antibiotic therapy within 4 weeks prior to screening
• History of cardiac disease or events according to the New York Health Association (NYHA) assessments. Clinically evident congestive heart failure as defined by NYHA Class 3 or 4 CHF or cardiac arrhythmia, including atrial fibrillation, if not adequately controlled
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
• Known HIV or Hepatitis B or C (active, previously treated or both)
• A history of other malignancy (except nonmelanoma skin cancer or carcinoma-in-situ of cervix), unless in CR and not receiving therapy for that disease for a minimum of 5 years
• Patients with known hypersensitivity to any of the components of the drugs to be administered on study
• Patients receiving concurrent investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority-approved indication)

Sponsors & Collaborators

• Cortice Biosciences, Inc.: lead

Study Sites (4)

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University

Baltimore, Maryland, 21231-1000, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Hospital Madrid

Madrid, 28250, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

TPI-287

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Sandra Silberman, MD

  SLS Oncology, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2010
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

US (3); ES (1)