Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer

NCT01946646 | Terminated Phase 1

• 1 other identifier: 201211048MPC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose

  Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: 1. grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more 2. grade 3 leucopenia and/or neutropenia with infection 3. grade 4 leucopenia and/or neutropenia lasting 3 days or more 4. grade 4 leucopenia and/or neutropenia requiring G-CSF 5. platelet \< 25,000/mm3 6. , grade 3 thrombocytopenia requiring transfusion 7. hemoglobin \< 8.0 g/dL g. serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine \>3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.

  6 weeks

• maximum-tolerated dose

  6 weeks

Study Arms (1)

S-1-CCRT

EXPERIMENTAL

There are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT

Drug: S-1-CCRT

Interventions

S-1-CCRT DRUG

S-1-CCRT

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
• no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
• presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
• age between 20 and 79 years at registration
• ECOG PS of 0 or 1
• adequate major organ functions
• ability to take the oral study medication (TS-1)
• no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
• voluntarily signed the written informed consent form

You may not qualify if:

• pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
• presence of diarrhea ≥ CTCAE v.4.03 grade 2
• concomitant active infection or significant co-morbid medical conditions
• moderate or severe ascites or pleural effusion that requires drainage
• central nervous system metastasis
• prior or concurrent malignancies within the last 3 years
• concomitant treatment with flucytosine, phenytoin or warfarin
• pregnant women or nursing mothers, or positive pregnancy test
• severe mental disorder
• judged ineligible by physician for participation in the study due to safety concern

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• TTY Biopharm: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 19, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

TW (1)