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Pemetrexed Followed by Docetaxel or in Reverse Sequence

Primary Purpose

Non-small-cell Lung Cancer

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Docetaxel and pemetrexed

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring lung cancer, docetaxel, pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV
aged 18 years or older
failed previous platinum-based chemotherapy
presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with spiral CT scan
performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
serum creatinine level 2.0 mg/dL or lower
serum bilirubin less than 1.5 times the upper limit of normal range (ULN)
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times the ULN (less than 5 times the ULN in liver metastases)
written informed consent to participate in the trial In addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial. Patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study.

Exclusion Criteria:

Active infection (at the discretion of the investigator).
Active central nervous system (CNS) metastases.
Breast feeding.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Use of any investigational agent in the month before enrollment into the study.
Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.

Sites / Locations

Taipei VGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

D followed by P

P followed by D

Arm Description

Docetaxel 60 mg/m2 intravenous infusion (IV) day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles), followed by pemetrexed 500 mg/m2 IV day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles).

Pemetrexed treatment followed by docetael (in reverse sequence of Arm "D followed by P"

Outcomes

Primary Outcome Measures

Incidence of grade III or IV leukopenia during treatment

Secondary Outcome Measures

progression-free survival

Full Information

NCT ID

NCT01442909

First Posted

May 25, 2008

Last Updated

September 27, 2011

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01442909

Brief Title

Pemetrexed Followed by Docetaxel or in Reverse Sequence

Official Title

Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.

Detailed Description

Docetaxel was the first third-generation anti-cancer drug found to have activity in second-line chemotherapy for NSCLC, with a prolongation of patient survival in phase III randomized trials comparing docetaxel with vinorelbine or ifosfamide, or with the best supportive care, for NSCLC patients who have failed previous chemotherapy; thus, it has been recommended for the second-line treatment of NSCLC. Four years after these trials, pemetrexed showed similar activity with less toxicity, when compared with docetaxel treatment in a phase III randomized trial of NSCLC patients previously treated with chemotherapy. Pemetrexed is a multitargeted antifolate which exhibits clinical activity in a variety of solid tumors, especially malignant mesothelioma and NSCLC. It inhibits thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed has confirmed activity against previously chemotherapy-treated NSCLC and has a better toxicity profile than docetaxel, in which study docetaxel dosage used was 75 mg/m2 intravenous infusion (IV) every 3 weeks. However, docetaxel dosage used in Japan and Taiwan is usually 60 mg/m2 every 3 weeks. Whether or not toxicity profiles of these two different drugs in same individual patients is similar to findings of patients who received specific drug only is unknown, so is unknown of toxicity profiles of docetaxel 60 mg/m2 every 3 weeks comparing alimta 500 mg/m2 every 3 weeks. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small-cell Lung Cancer

Keywords

lung cancer, docetaxel, pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

D followed by P

Arm Type

Active Comparator

Arm Description

Arm Title

P followed by D

Arm Type

Active Comparator

Arm Description

Pemetrexed treatment followed by docetael (in reverse sequence of Arm "D followed by P"

Intervention Type

Drug

Intervention Name(s)

Docetaxel and pemetrexed

Other Intervention Name(s)

taxotere, alimta

Intervention Description

docetaxel 60mg/m2 every 3 weeks for 4 cycles followed by pemetrexed 500mg/m2 every 3 weeks for 4 cycles; or in reverse sequence.

Primary Outcome Measure Information:

Title

Incidence of grade III or IV leukopenia during treatment

Time Frame

one year

Secondary Outcome Measure Information:

Title

progression-free survival

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV aged 18 years or older failed previous platinum-based chemotherapy presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with spiral CT scan performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl serum creatinine level 2.0 mg/dL or lower serum bilirubin less than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times the ULN (less than 5 times the ULN in liver metastases) written informed consent to participate in the trial In addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial. Patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study. Exclusion Criteria: Active infection (at the discretion of the investigator). Active central nervous system (CNS) metastases. Breast feeding. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). Use of any investigational agent in the month before enrollment into the study. Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuh-Min Chen, MD, PhD.

Organizational Affiliation

Chest Department, Taipei VGH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei VGH

City

Taipei City

ZIP/Postal Code

112

Country

Taiwan

12. IPD Sharing Statement

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Pemetrexed Followed by Docetaxel or in Reverse Sequence

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