A Phase 2 interventional study of Carboplatin and Docetaxel in Lung Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-07.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy.
PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
OBJECTIVES:
Primary
Secondary
OUTLINE:
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
Exclusion Criteria:
Drug: Carboplatin · Drug: Docetaxel · Radiation: radiation therapy
Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.
Also known as: None specified
Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).
Also known as: Taxotere
Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
Also known as: none specified
Overall Survival
Months from on-study to expired/last date known alive.
Time frame: 14.95 months (average duration, on study date to off-study date)
Overall Response Rate
Patient response to treatment per RECIST: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Time frame: on-study date to date of best response
Time to Disease Progression
Time to disease progression in months
Time frame: on-study date to date of progression
Number of Participants With Adverse Events by Grade
Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event
Time frame: 30 days after last treatment.
Recruitment Period = 2/18/2004 through 1/23/2007
| Milestone | Chemo-radio Therapy |
|---|---|
| Started | 63 |
| Completed | 39 |
| Not completed | 24 |
| Withdrew: Death | 3 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Adverse event | 9 |
| Withdrew: Disease progression | 7 |
Months from on-study to expired/last date known alive.
| Months | Chemo-radio Therapy |
|---|---|
| Overall Survival | 11 (0 to 47) |
Patient response to treatment per RECIST: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
| participants | Chemo-radio Therapy |
|---|---|
| Complete Response | 6 |
| Partial Response | 33 |
| Progressive Disease | 5 |
| Stable Disease | 13 |
Time to disease progression in months
| Months | Chemo-radio Therapy |
|---|---|
| Time to Disease Progression | 5 (1 to 25) |
Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event
| participants | Chemo-radio Therapy |
|---|---|
| Grade 1 | 11 |
| Grade 2 | 19 |
| Grade 3 | 35 |
| Grade 4 | 12 |
| Grade 5 | 3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemo-radio Therapy | — | 37/63 (58.7%) | 13/63 (20.6%) |
| Event | Chemo-radio Therapy |
|---|---|
| Dysphagia, esophagitis, odynophagiaGastrointestinal disorders | 14/63 |
| DehydrationMetabolism and nutrition disorders | 8/63 |
| Weight lossInvestigations | 6/63 |
| ThrombosisCardiac disorders | 6/63 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/63 |
| Infection without neutropeniaMetabolism and nutrition disorders | 5/63 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 4/63 |
| NauseaGastrointestinal disorders | 4/63 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/63 |
| HypotensionVascular disorders | 3/63 |
| Event | Chemo-radio Therapy |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 5/63 |
| Weight lossInvestigations | 5/63 |
| FeverGeneral disorders | 3/63 |
| DehydrationMusculoskeletal and connective tissue disorders | 3/63 |
| Age, Categorical(Participants) | Chemo-radio Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 36 |
| >=65 years | 27 |
| Age Continuous(years) | Chemo-radio Therapy |
|---|---|
| Mean | 63 ± 1 |
| Sex: Female, Male(Participants) | Chemo-radio Therapy |
|---|---|
| Female | 25 |
| Male | 38 |
| Region of Enrollment(participants) | Chemo-radio Therapy |
|---|---|
| United States | 63 |
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center