Trial · NCT00613626

Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer

NCT00613626, Phase 2, Completed, Hoosier Cancer Research Network; results first posted 2015-11-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer. Trials, record NCT00613626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00613626

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Trial

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

Title: Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer
NCT number: NCT00613626
Status: Completed
Phases: Phase 2
Enrollment: 74 participants, actual
Lead sponsor: Hoosier Cancer Research Network
Conditions: Small Cell Lung Cancer
Interventions: Cisplatin, Etoposide, Placebo, ZD6474
First posted: 2008-02-13
Last updated: 2020-02-11
Results first posted: 2015-11-18
Limitations and caveats: The primary object analysis was under powered. The sample size calculation determined 34 subjects per arm, however the actual primary objective analysis was based on 31 subjects per arm.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Time to Disease Progression - Median Time to Progression and Log-Rank Test	24 months	Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.
Secondary	Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	6 weeks (2 Cycles)	Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.
Secondary	Measure the Response Rate (CR + PR) in Each Arm	24 months	Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: \>=30% decrease in the sum of the longest diameter of target lesions.
Secondary	Measure Disease Control Rate (CR + PR+ SD) in Each Arm	24 months	Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( \>=20% increase in the sum of the longest diameter of the target lesions).
Secondary	Measure Overall Survival for Each Arm	24 months
Secondary	Assess VEGF Polymorphisms and Correlate Subject Response	24 months

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Disease Progression - Median Time to Progression and Log-Rank Test	24 months	Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)	Months	MEDIAN
SECONDARY	Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	6 weeks (2 Cycles)	The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.	percentage of participants	NUMBER
SECONDARY	Measure the Response Rate (CR + PR) in Each Arm	24 months	12 participants are excluded due to missing data.	percentage of participants	NUMBER
SECONDARY	Measure Disease Control Rate (CR + PR+ SD) in Each Arm	24 months	12 participants were not analyzed due to missing data.	percentage of participants	NUMBER
SECONDARY	Measure Overall Survival for Each Arm	24 months		Months	MEDIAN
SECONDARY	Assess VEGF Polymorphisms and Correlate Subject Response	24 months	This data was not collected for the safety lead-in participants.	probability	NUMBER

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Time to Disease Progression - Median Time to Progression and Log-Rank Test	Arm A: ZD6474 Matched Placebo		5.68	95% Confidence Interval 3.98 to 6.41	Months
Time to Disease Progression - Median Time to Progression and Log-Rank Test	Arm B: ZD6474		5.62	95% Confidence Interval 5.09 to 6.24	Months
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	Arm A: ZD6474 Matched Placebo	Grade 3/4 Hematologic Toxicity	11.00		percentage of participants
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	Arm B: ZD6474 + Safety Lead-In	Grade 3/4 Hematologic Toxicity	13.75		percentage of participants
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	Arm A: ZD6474 Matched Placebo	Grade 3/4 Non-Hematologic Toxicity	2.71		percentage of participants
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	Arm B: ZD6474 + Safety Lead-In	Grade 3/4 Non-Hematologic Toxicity	4.30		percentage of participants
Measure the Response Rate (CR + PR) in Each Arm	Arm A: ZD6474 Matched Placebo		65.38	95% Confidence Interval 47.10 to 83.67	percentage of participants
Measure the Response Rate (CR + PR) in Each Arm	Arm B: ZD6474		50.00	95% Confidence Interval 31.48 to 68.52	percentage of participants
Measure Disease Control Rate (CR + PR+ SD) in Each Arm	Arm A: ZD6474 Matched Placebo		73.08	95% Confidence Interval 56.03 to 90.13	percentage of participants
Measure Disease Control Rate (CR + PR+ SD) in Each Arm	Arm B: ZD6474		75.00	95% Confidence Interval 58.96 to 91.04	percentage of participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: ZD6474 Matched Placebo	33
Overall Study	STARTED	Arm B: ZD6474	34
Overall Study	STARTED	Safety Lead-In	7
Overall Study	1st Dose ZD6474	Arm A: ZD6474 Matched Placebo	33
Overall Study	1st Dose ZD6474	Arm B: ZD6474	34
Overall Study	1st Dose ZD6474	Safety Lead-In	7
Overall Study	COMPLETED	Arm A: ZD6474 Matched Placebo	33
Overall Study	COMPLETED	Arm B: ZD6474	33
Overall Study	COMPLETED	Safety Lead-In	7
Overall Study	NOT COMPLETED	Arm A: ZD6474 Matched Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events324

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	ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	Arm A: ZD6474 Matched Placebo	5	33	9
other	ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	Arm B: ZD6474	5	41	5
other	ALKALINE PHOSPHATASE	Investigations	Arm A: ZD6474 Matched Placebo	5	33	5
other	ALKALINE PHOSPHATASE	Investigations	Arm B: ZD6474	4	41	5
other	ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	Immune system disorders	Arm A: ZD6474 Matched Placebo	0	33	0
other	ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	Immune system disorders	Arm B: ZD6474	2	41	2
other	ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	Investigations	Arm A: ZD6474 Matched Placebo	3	33	4
other	ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	Investigations	Arm B: ZD6474	2	41	2
other	ANOREXIA	Gastrointestinal disorders	Arm A: ZD6474 Matched Placebo	11	33	12
other	ANOREXIA	Gastrointestinal disorders	Arm B: ZD6474	13	41	14

1 to 10 of 324Source ClinicalTrials.gov

See all 324 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: ZD6474 Matched Placebo
Total, all-cause mortality	Arm B: ZD6474
Total, other adverse events	Arm A: ZD6474 Matched Placebo	32	33
Total, other adverse events	Arm B: ZD6474	39	41
Total, serious adverse events	Arm A: ZD6474 Matched Placebo	8	33
Total, serious adverse events	Arm B: ZD6474	14	41

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm B: ZD6474 vs Arm A: ZD6474 Matched Placebo: serious adverse events

Source Trial comparisons

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/NCT00613626

GET https://conductscience.org/api/trials/v1/NCT00613626/results?page=2

API reference For AI assistants