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TerminatedNCT00145418Updated Jun 30, 2014Results posted

Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

A Phase 2 interventional study of Oxaliplatin + Docetaxel in Carcinoma, Non-Small-Cell Lung, sponsored by Oncology Specialists, S.C.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-30.

Sponsored by Oncology Specialists, S.C. · Phase 2, Interventional, and Treatment

Why this study was terminated
low enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

Read the detailed description

This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:

  • oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
  • docetaxel 30mg/m2 on Days 1 and 8

Cycles are to be repeated every 28 days for a maximum of 6 cycles.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Non small Cell Lung Cancer Stage IIIb and IV
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Oncology Specialists, S.C. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
  • Patients must have measurable disease
  • Age greater than or equal to 18 years
  • ECOG performance score of 0, 1, or 2
  • Absolute neutrophil count (ANC) > 1,500
  • Platelets > 100,000
  • Serum creatinine \< 1.5mg/dL
  • Serum total bilirubin \< 1.5mg/dL
  • Alkaline phosphatase \< 3 times the upper limit of normal
  • SGOT/SGPT \< 3 times the upper limit of normal
  • Patients must be recovered from the effects of any prior surgery or RT.
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
  • Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.

Exclusion criteria

Exclusion Criteria:

  • Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
  • Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of \< 1.0 mg/dL
  • Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
  • Patients who have had prior chemotherapy for lung cancer
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
  • Grade 2 peripheral neuropathy
  • Patients who are pregnant or lactating
  • Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
  • History of allogeneic transplant
  • Known HIV, hepatitis B or C (active, previously treated, or both)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.

    Drug: Oxaliplatin + Docetaxel

Interventions

  • DrugOxaliplatin + Docetaxel

    Oxaliplatin 85mg/m2 Docetaxel 30mg.m2

    Also known as: Eloxatin

06

What researchers measure

Primary outcomes

  1. Response Rate

    Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.

    Time frame: Response is measured every 2 cycles until disease progression

Secondary outcomes

  1. Time to Progression

    Progression is measured from each participants start of study until removal from treatment.

    Time frame: <1 cycle to 6 cycles of treatment

  2. Duration of Response

    Duration of response is a measure of how long the participants response to therapy was maintained.

    Time frame: 0 -12 months

  3. Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.

    Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.

    Time frame: day one of cycle one until participant removed from trial

07

Results

Posted Jan 31, 2013
Limitations and caveats
Due to lack of recruitment, the study was closed early and conclusions should not necessarily be drawn from the data presented for duration of response

Participant flow

patients recruited from clinical practice.

Participant flow — Overall Study
MilestoneOxaliplatin + Docetaxel
Started15
Completed15
Not completed0

Outcome measures

PrimaryResponse Rate

Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.

Time frame:
Response is measured every 2 cycles until disease progression
Reported as:
Number · Participants
Response Rate
ParticipantsOxaliplatin + Docetaxel
partial response7
complete response0
stable disease1
SecondaryTime to Progression

Progression is measured from each participants start of study until removal from treatment.

Time frame:
<1 cycle to 6 cycles of treatment
Reported as:
Median · months
Time to Progression
monthsOxaliplatin + Docetaxel
Time to Progression2.4 (0 to 6)
SecondaryDuration of Response

Duration of response is a measure of how long the participants response to therapy was maintained.

Time frame:
0 -12 months
Reported as:
Median · months
Duration of Response
monthsOxaliplatin + Docetaxel
Duration of Response7.9 (0 to 12)
SecondarySafety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.

Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.

Time frame:
day one of cycle one until participant removed from trial
Reported as:
Number · participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.
participantsOxaliplatin + Docetaxel
Grade 3 or 4 anemia1
grade 3 or 4 thrombocytopenia1
Grade 3 or 4 fatigue5
Grade 3 or 4 dehydration2
Grade 3 or 4 nausea1
Grade 3 or 4 diarrhea2
Grade 3 or 4 anorexia1
Grade 3 or 4 neutropenia3
Grade 3 or 4 vomiting2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxaliplatin + Docetaxel—9/15 (60%)15/15 (100%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventOxaliplatin + Docetaxel
DehydrationGastrointestinal disorders2/15
Catheter infectionInfections and infestations1/15
nauseaGastrointestinal disorders1/15
clostridium difficile colitisGastrointestinal disorders1/15
hemoptysisRespiratory, thoracic and mediastinal disorders1/15
fatigueGeneral disorders1/15
painNervous system disorders1/15
chest painRespiratory, thoracic and mediastinal disorders1/15
pericardial effusionCardiac disorders1/15
diarrheaGastrointestinal disorders1/15
Most frequent other events
Showing 10 of 15
Most frequent other events
EventOxaliplatin + Docetaxel
neuropathyNervous system disorders12/15
anemiaBlood and lymphatic system disorders12/15
NauseaGastrointestinal disorders10/15
fatigueGeneral disorders7/15
HeadacheNervous system disorders6/15
diarrheaGastrointestinal disorders6/15
neutropeniaBlood and lymphatic system disorders6/15
dysguesiaNervous system disorders5/15
alopeciaSkin and subcutaneous tissue disorders5/15
thrombocytopeniaVascular disorders5/15

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Oxaliplatin + Docetaxel
<=18 years0
Between 18 and 65 years8
>=65 years7
Sex: Female, Male
Sex: Female, Male(Participants)Oxaliplatin + Docetaxel
Female5
Male10
Region of Enrollment
Region of Enrollment(participants)Oxaliplatin + Docetaxel
United States15
08

Study locations

1 site
  • Oncology Specialists, SC
    Park Ridge, Illinois 60068, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00145418
Lead sponsor
Oncology Specialists, S.C.
Collaborators
Sanofi-Synthelabo
Responsible party
Dr. Sigrun Hallmeyer (Principal Investigator, Oncology Specialists, S.C.) — Principal investigator
First posted
Sep 5, 2005
Start date
Feb 2005
Primary completion
Aug 2009
Completion
Mar 2010
Results posted
Jan 31, 2013
Last update
Jun 30, 2014

Study contacts

Chadi Nabhan, MD
principal investigator · Oncology Specialists, SC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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