Trial · NCT00459121
Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
NCT00459121, Phase 2, Terminated, Barbara Ann Karmanos Cancer Institute; results first posted 2012-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery. Trials, record NCT00459121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00459121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
- NCT number
- NCT00459121
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Lung Cancer
- Interventions
- carboplatin, paclitaxel, Zactima, neoadjuvant therapy
- First posted
- 2007-04-11
- Last updated
- 2019-03-26
- Results first posted
- 2012-12-07
- Limitations and caveats
- This was a single center study. We did not accrue enough particpants in a timely fashion and a joint decision was made with AstraZeneca to terminate the study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Resection (R0) Rate | Following three cycles of pre-operative zactima and carboplatin/paclitaxel | |
| Secondary | Post-Operative Mortality Rate | at 30 days | |
| Secondary | Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy | Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel | Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT \[AST\], SGPT \[ALT\], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel. |
| Secondary | Assess the Clinical Response Rate of the Proposed Pre-operative Regimen | End of three cycles of treatment | Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy |
| Secondary | Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen. | 30 days post surgery | Evaluation of the number of patients who have no evidence of tumor in the resected tumor. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Resection (R0) Rate | Following three cycles of pre-operative zactima and carboplatin/paclitaxel | No analysis was completed only 2 patients enrolled, study closed due to slow accrual. | ||
| SECONDARY | Post-Operative Mortality Rate | at 30 days | No analysis was completed only 2 patients enrolled, study closed due to slow accrual. | ||
| SECONDARY | Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy | Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel | No analysis was completed only 2 patients enrolled, study closed due to slow accrual. | ||
| SECONDARY | Assess the Clinical Response Rate of the Proposed Pre-operative Regimen | End of three cycles of treatment | No analysis was completed only 2 patients enrolled, study closed due to slow accrual. | ||
| SECONDARY | Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen. | 30 days post surgery | No analysis was completed only 2 patients enrolled, study closed due to slow accrual. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zactima, Paclitaxel, Carboplatin | 2 | |
| Overall Study | COMPLETED | Zactima, Paclitaxel, Carboplatin | 2 | |
| Overall Study | NOT COMPLETED | Zactima, Paclitaxel, Carboplatin | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased ANC | Blood and lymphatic system disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 2 | 2 | 2 |
| other | Cough | General disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 1 |
| other | Fatigue | General disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 2 | 2 | 2 |
| other | Bicarbonate | Metabolism and nutrition disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 1 |
| other | Hyperglycemia | Blood and lymphatic system disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 2 | 2 | 2 |
| other | Nausea | Gastrointestinal disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 2 | 2 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 1 |
| other | Decreased WBC count | Blood and lymphatic system disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 1 |
| other | Constipation | Gastrointestinal disorders | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 1 | 2 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | ||
| Total, other adverse events | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 2 | 2 |
| Total, serious adverse events | Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00459121
GET https://conductscience.org/api/trials/v1/NCT00459121/registered