Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy (PACT-18)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by IRCCS San Raffaele.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
IRCCS San Raffaele
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01339754
First received: April 20, 2011
Last updated: February 9, 2012
Last verified: April 2011
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Purpose
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: trabectedin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial |
Resource links provided by NLM:
Further study details as provided by IRCCS San Raffaele:
Primary Outcome Measures:
- Progression-free survival (PFS) rate at 6 months [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]CT scan
Secondary Outcome Measures:
- Safety profile [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]outpatient visit, laboratory findings
- Response rate and response duration [ Time Frame: every 2 months ] [ Designated as safety issue: No ]CT scan
- Overall survival [ Time Frame: every 3 weeks during therapy, every 2-3 months thereafter ] [ Designated as safety issue: No ]outpatient visit, phone interview
- PFS rate at 9 and 18 weeks [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]CT scan
- Identify biomarkers predictive for resistance or sensitivity to trabectedin [ Time Frame: at trial start ] [ Designated as safety issue: No ]tissue, blood, serum collection
- Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity [ Time Frame: based on a pre-definid sample collection schedule ] [ Designated as safety issue: No ]blood samples
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: trabectedin
1.3 mg/mq as a 3 hour continuous infusion every three weeks
Other Name: YONDELIS
OBJECTIVES:
Primary
- To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy.
Secondary
- To assess the safety profile of this drug.
- To assess the response rate and response duration.
- To assess the overall survival of these patients.
- To assess the PFS rate at 9 and 18 weeks.
- To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies.
OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies.
After completion of study treatment, patients are followed up periodically.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
Metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy
- May be given with neoadjuvant, adjuvant, or palliative therapy
- Measurable disease according to RECIST criteria
- No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Bone marrow, liver, and kidney function normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
No severe comorbidities, including any of the following:
- Cardiac disease
- History of psychiatric disability
- No other prior or concurrent malignancy except surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, and other neoplasms without evidence of disease for ≥ 5 years
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior second-line chemotherapy
- No other concurrent chemotherapy or target therapy
- No concurrent treatment with other experimental drugs
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Michele Reni, MD, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01339754 History of Changes |
| Other Study ID Numbers: | CDR0000698981, PACT-18, 2010-024287-17 |
| Study First Received: | April 20, 2011 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by IRCCS San Raffaele:
|
recurrent pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Trabectedin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013