Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01555710
First received: March 12, 2012
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.


Condition Intervention Phase
Extensive-Stage Small Cell Lung Cancer
Drug: Carboplatin
Drug: Palifosfamide-tris
Drug: Etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest) ] [ Designated as safety issue: No ]
  • Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13 [ Time Frame: Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed ] [ Designated as safety issue: No ]
  • Response Duration [ Time Frame: Time from the date of first objective response (partial or complete response), with subsequent confirmation, until the date of disease progression or the occurrence of death ] [ Designated as safety issue: No ]
  • Safety parameters (number of adverse events as well as number of findings from physical examinations, ECGs, vital signs, and clinical laboratory results)using NCI CTCAE v. 4.03 [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 548
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palifosfamide-tris plus Carboplatin and Etoposide
Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Drug: Carboplatin
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Drug: Palifosfamide-tris
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Drug: Etoposide
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Active Comparator: Carboplatin plus Etoposide
Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Drug: Etoposide
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Drug: Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented extensive-stage small cell lung cancer.
  • Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer.
  • ECOG Performance Status of 0, 1 or 2.
  • Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests.
  • Male and female patients must agree to use a highly reliable method of birth control during study participation.
  • Able to provide informed consent

Exclusion Criteria:

  • Previously untreated (non-irradiated), symptomatic brain metastases.
  • Known allergy to any of the study drugs or their excipients.
  • Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
  • Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consultation with the medical monitor provided the patient's prognosis is best defined by the extensive-stage small cell lung cancer).
  • Currently pregnant or nursing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555710

  Show 79 Study Locations
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01555710     History of Changes
Other Study ID Numbers: IPM3002
Study First Received: March 12, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
France: Institutional Ethical Committee
France: Ministry of Health
Germany: Ethics Commission
Germany: Ministry of Health
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
Italy: Ethics Committee
Italy: Ministry of Health
Ukraine: Ethics Committee
Ukraine: Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Taiwan : Food and Drug Administration
Taiwan: Institutional Review Board
Israel: Ethics Commission
Israel: Ministry of Health
Hungary: Institutional Ethics Committee
Hungary: Ministry of Health, Social and Family Affairs

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Isophosphamide mustard
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 30, 2014