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:
ZIOPHARM
Information provided by (Responsible Party):
ZIOPHARM
ClinicalTrials.gov Identifier:
NCT01555710
First received: March 12, 2012
Last updated: May 20, 2013
Last verified: May 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555710
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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 |
Etoposide phosphate Isophosphamide mustard Ifosfamide Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013