Trial · NCT00880334

Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

NCT00880334, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-06-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC. Trials, record NCT00880334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00880334

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC
NCT number: NCT00880334
Status: Completed
Phases: Phase 2
Enrollment: 149 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Transitional Cell Carcinoma, Bladder Cancer
Interventions: Docetaxel, vandetanib, Placebo
First posted: 2009-04-13
Last updated: 2018-09-18
Results first posted: 2014-06-04

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Progression-Free Survival (PFS)	Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).	PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary	Grade 3-5 Toxicity Rate	Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).	Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment during the randomized phase.
Secondary	Median Overall Survival	Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).	Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.
Secondary	Objective Response Rate	Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).	Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment during the randomized phase. Patients without measurable disease only at baseline are included, based on status of non-target lesions.Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

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	Median Progression-Free Survival (PFS)	Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).	The analysis dataset is comprised of all eligible and treated patients.	months	MEDIAN
SECONDARY	Grade 3-5 Toxicity Rate	Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).	The analysis dataset is comprised of all eligible and treated patients.	percentage of participants	NUMBER
SECONDARY	Median Overall Survival	Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).	The analysis dataset is comprised of all eligible and treated patients.	months	MEDIAN
SECONDARY	Objective Response Rate	Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).	The analysis dataset is comprised of all eligible and treated patients.	percentage of participants	NUMBER
POST_HOC	Disease Control Rate	Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Median Progression-Free Survival (PFS)	Vandetanib and Docetaxel	2.56	95% Confidence Interval 1.81 to 3.06	months
Median Progression-Free Survival (PFS)	Placebo and Docetaxel	1.58	95% Confidence Interval 1.48 to 3.09	months
Grade 3-5 Toxicity Rate	Vandetanib and Docetaxel	73	95% Confidence Interval 61 to 83	percentage of participants
Grade 3-5 Toxicity Rate	Placebo and Docetaxel	57	95% Confidence Interval 45 to 69	percentage of participants
Median Overall Survival	Vandetanib and Docetaxel	5.85	95% Confidence Interval 5.22 to 7.00	months
Median Overall Survival	Placebo and Docetaxel	7.03	95% Confidence Interval 5.19 to 10.41	months
Objective Response Rate	Vandetanib and Docetaxel	7.1	95% Confidence Interval 2.4 to 15.9	percentage of participants
Objective Response Rate	Placebo and Docetaxel	11.1	95% Confidence Interval 4.9 to 20.8	percentage of participants
Disease Control Rate	Vandetanib and Docetaxel	51	95% Confidence Interval 39 to 64	percentage of participants
Disease Control Rate	Placebo and Docetaxel	42	95% Confidence Interval 30 to 54	percentage of participants

Source ClinicalTrials.gov

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized Phase	STARTED	Vandetanib and Docetaxel	74
Randomized Phase	STARTED	Placebo and Docetaxel	75
Randomized Phase	Eligible & Treated	Vandetanib and Docetaxel	70
Randomized Phase	Eligible & Treated	Placebo and Docetaxel	72
Randomized Phase	COMPLETED	Vandetanib and Docetaxel	70
Randomized Phase	COMPLETED	Placebo and Docetaxel	35
Randomized Phase	NOT COMPLETED	Vandetanib and Docetaxel	4
Randomized Phase	NOT COMPLETED	Placebo and Docetaxel	40
Crossover Phase	STARTED	Vandetanib and Docetaxel	0
Crossover Phase	STARTED	Placebo and Docetaxel	37

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events378

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
other	Abdomen, pain	Gastrointestinal disorders	Vandetanib and Docetaxel	1	70
other	Abdomen, pain	Gastrointestinal disorders	Placebo and Docetaxel	0	72
other	Abdomen, pain	Gastrointestinal disorders	Placebo and Docetaxel-Crossover	0	37
other	Alkaline phosphatase	Investigations	Vandetanib and Docetaxel	0	70
other	Alkaline phosphatase	Investigations	Placebo and Docetaxel	1	72
other	Alkaline phosphatase	Investigations	Placebo and Docetaxel-Crossover	0	37
other	Alopecia	Skin and subcutaneous tissue disorders	Vandetanib and Docetaxel	3	70
other	Alopecia	Skin and subcutaneous tissue disorders	Placebo and Docetaxel	1	72
other	Alopecia	Skin and subcutaneous tissue disorders	Placebo and Docetaxel-Crossover	0	37
other	Anorexia	Metabolism and nutrition disorders	Vandetanib and Docetaxel	3	70

1 to 10 of 378Source ClinicalTrials.gov

See all 378 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vandetanib and Docetaxel
Total, all-cause mortality	Placebo and Docetaxel
Total, all-cause mortality	Placebo and Docetaxel-Crossover
Total, other adverse events	Vandetanib and Docetaxel	22	70
Total, other adverse events	Placebo and Docetaxel	12	72
Total, other adverse events	Placebo and Docetaxel-Crossover	5	37
Total, serious adverse events	Vandetanib and Docetaxel	42	70
Total, serious adverse events	Placebo and Docetaxel	26	72
Total, serious adverse events	Placebo and Docetaxel-Crossover	6	37

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22184381	BACKGROUND

Source PubMed

Grants0

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.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00880334

GET https://conductscience.org/api/trials/v1/NCT00880334/events?page=2

API reference For AI assistants