Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy (PACT-18)

San Donato Group (GSD)

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: trabectedin

Study type: Interventional

Funder types: Other

Identifiers

NCT01339754

2010-024287-17 (EudraCT Number)

CDR0000698981

PACT-18 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

trabectedin

Experimental group

Description:

1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

Treatment:

Drug: trabectedin

Drug: trabectedin