Sirolimus in Treating Patients With Advanced Pancreatic Cancer

NCT00499486 | Completed Phase 2 Results DMC

• 4 other identifiers: JHOC-J0415, CDR0000549899P30CA006973JHOC-J0415JHOC-04-06-16-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients With Overall Survival at 6 Months

  6- month survival rate (6mSR)

• Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.

  response at 2 and 6 months

• Severity of Adverse Events as Assessed by NCI CTCAE v3.0

  6 months

Study Arms (1)

Sirolimus

EXPERIMENTAL

Sirolimus 5mg. po QD continously (28 days=cycle)

Drug: sirolimus

Interventions

sirolimus DRUG

Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.

Also known as: rapamycin

Sirolimus

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the pancreas
• Locally-advanced or advanced disease which has progressed after one prior gemcitabine-containing regimen
• Unidimensionally measurable disease (defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan) OR evaluable disease
• Tumor tissue available for IHC assessment OR willingness to undergo a safe biopsy of tumor tissue

You may not qualify if:

• Histologic or cytologic diagnosis that is not consistent with adenocarcinoma, including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, or small or large cell carcinoma or lymphoma
• Adenocarcinoma arising from a site other than the pancreas (e.g., distal common bile duct, ampulla of vater or periampullary duodenum)
• Known brain metastases
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• WBC \> 3,500 cells/mm³
• ANC \> 1,500 cells/mm³
• Hemoglobin \> 9 g/dL
• Serum creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 2 mg/dL
• ALT, AST, and alkaline phosphatase ≤ 5 times upper limit of normal
• Triglycerides and total cholesterol \< 2 times upper limit of normal
• Not pregnant or nursing
• Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including immunodeficiency and chronic treatment with immunosuppressors
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

• Garrido-Laguna I, Tan AC, Uson M, Angenendt M, Ma WW, Villaroel MC, Zhao M, Rajeshkumar NV, Jimeno A, Donehower R, Iacobuzio-Donahue C, Barrett M, Rudek MA, Rubio-Viqueira B, Laheru D, Hidalgo M. Integrated preclinical and clinical development of mTOR inhibitors in pancreatic cancer. Br J Cancer. 2010 Aug 24;103(5):649-55. doi: 10.1038/sj.bjc.6605819. Epub 2010 Jul 27.

  PMID: 20664591 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Hidalgo
• Organization: The Sidney Kimmel Comprehensive Cancer Centre at Johns Hopkins

mhidalgo@cnio.es

Study Officials

• Manuel Hidalgo, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: January 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: June 1, 2009
• Last Updated: October 19, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-10

Locations

US (1)