Genital Neoplasms, FemalePhase 3NCT00191646

An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy

A Phase 3 study testing Gemcitabine, Paclitaxel and Carboplatin in people with Genital Neoplasms, Female and Fallopian Tube Neoplasms, run by Eli Lilly and Company at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms
What is being tested?: Gemcitabine, Paclitaxel and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 919 participants
Where: 55 sitesin 2 countries
Study dates: Oct 2002to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
Patients must be enrolled no more than twelve weeks postoperatively.
Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.

Who cannot join

Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.

Trial locations and contacts

55 sites in 2 countries.

Country

City, postcode or hospital

55 sites in 2 countries

United States54 sites

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Atlanta, Georgia, 30342
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Austin, Texas, 78735
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Billings, Montana, 59107
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Chattanooga, Tennessee, 37404
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Columbia, South Carolina, 29210
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Columbus, Ohio, 43222
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Dayton, Ohio, 45429
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Detroit, Michigan, 48201
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Duluth, Minnesota, 55805
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Dunmore, Pennsylvania, 18512
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Durham, North Carolina, 27710
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Englewood, Colorado, 80113
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Fort Myers, Florida, 33901
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Grand Rapids, Michigan, 49546
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Greenville, North Carolina, 27858
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Greenville, South Carolina, 29601
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Hackensack, New Jersey, 07601
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Indianapolis, Indiana, 46260
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Johnstown, Pennsylvania, 15905
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37920
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Las Vegas, Nevada, 89109
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Little Rock, Arkansas, 72205
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Los Gatos, California, 95032
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Lubbock, Texas, 79410
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Madison, Wisconsin, 53792
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Memphis, Tennessee, 38120
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Metairie, Louisiana, 70006
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Minneapolis, Minnesota, 55455
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Modesto, California, 95350
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New Orleans, Louisiana, 70121
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Newark, Delaware, 19713
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Oklahoma City, Oklahoma, 73112
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Palatine, Illinois, 60067
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Phoenix, Arizona, 85006
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Pittsburgh, Pennsylvania, 15224
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Providence, Rhode Island, 02905
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Reno, Nevada, 89502
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Roanoke, Virginia, 24014
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Rochester, Minnesota, 55905
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Rochester, New York, 14620
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Salt Lake City, Utah, 84106
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San Diego, California, 92121
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Savannah, Georgia, 31404
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Sayre, Pennsylvania, 18840
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Scarborough, Maine, 04074
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Seattle, Washington, 98104
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South Bend, Indiana, 46617
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South Miami, Florida, 33143
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St Louis, Missouri, 63141
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Sunrise, Florida, 33323

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Puerto Rico1 site

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San Juan, 009362712

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About this study

Official title: Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian, Primary Peritoneal Cancer or Fallopian Tube Carcinoma

Read the detailed description

This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.

Conditions: Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Peritoneal Neoplasms
Being tested: Gemcitabine, Paclitaxel, Carboplatin
Medical subject headings: Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GemcitabineDrug
Also called LY188011, Gemzar
1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles
If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
PaclitaxelDrug
175 mg/m^2, IV, Day 1, q 21 days x 6 cycles
If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year)
If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity
CarboplatinDrug
Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles
Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles

Study groups in NCT00191646
Study group	Role	What they receive
Gemcitabine/Carboplatin	Experimental	Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles Receives: Drug: Gemcitabine; Drug: Carboplatin
Paclitaxel/Carboplatin	Active comparator	Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Measured: Baseline to measured progressive disease or death up to 82 months

Secondary outcomes (3)

Proportion of Participants With Response (Response Rate)
Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).
Measured: Baseline to measured progressive disease up to 82 months
Time to Treatment Failure
Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Measured: Baseline to stopping treatment up to 82 months
Overall Survival
Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Measured: Baseline to death from any cause up to 82 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Aug 2009

First posted19 Sep 2005 (estimated)
Study startOct 2002
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 919 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191646
Sponsor's protocol ID: 6891
Other IDs: B9E-US-S302
Status last verified: Feb 2011
First submitted: 12 Sep 2005
Last updated: 4 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian, Primary Peritoneal Cancer or Fallopian Tube Carcinoma
ClinicalTrials.gov ID: NCT00191646
Acronym / sponsor ID: 6891
Conditions: Genital Neoplasms, Female, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Peritoneal Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 919 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 9 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gemcitabine/Carboplatin	Experimental	Drug: Gemcitabine, Drug: CarboplatinGemcitabine 1000 milligrams per meter square (mg/m^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles
Paclitaxel/Carboplatin	Active comparator	Drug: Paclitaxel, Drug: CarboplatinPaclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
Patients must be enrolled no more than twelve weeks postoperatively.
Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.

Key exclusion criteria (4 listed)

Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GemcitabineAlso: LY188011, Gemzar1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity	Drug	Gemcitabine/Carboplatin
Paclitaxel175 mg/m^2, IV, Day 1, q 21 days x 6 cycles If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year) If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity	Drug	Paclitaxel/Carboplatin
CarboplatinGemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles	Drug	Gemcitabine/Carboplatin, Paclitaxel/Carboplatin

Primary outcome

Progression Free Survival (PFS)
Time frame: Baseline to measured progressive disease or death up to 82 months
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.

3 secondary outcomes

Proportion of Participants With Response (Response Rate)
Time frame: Baseline to measured progressive disease up to 82 months
Time to Treatment Failure
Time frame: Baseline to stopping treatment up to 82 months
Overall Survival
Time frame: Baseline to death from any cause up to 82 months

Results and safety

Results posted to the registry on 9 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine/Carboplatin	417	246
Paclitaxel/Carboplatin	414	261

Primary outcome: Progression Free Survival (PFS)

Time frame: Baseline to measured progressive disease or death up to 82 months. Median (95% Confidence Interval). Unit: Months

Measure	Gemcitabine/Carboplatin n = 414	Paclitaxel/Carboplatin n = 413
Value	20.0 (17.9 to 22.2)	22.2 (19.0 to 25.7)

Gemcitabine/Carboplatin vs Paclitaxel/Carboplatin: p = 0.199, Log Rank

Population analysed: Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine/Carboplatin Induction	96 of 412 (23.3%)	404 of 412 (98.1%)	Not reported
Paclitaxel/Carboplatin Induction	72 of 408 (17.6%)	394 of 408 (96.6%)	Not reported
Consolidation (Gemcitabine to Paclitaxel)	14 of 169 (8.3%)	157 of 169 (92.9%)	Not reported
Consolidation (Paclitaxel to Paclitaxel)	12 of 183 (6.6%)	170 of 183 (92.9%)	Not reported
Crossover (Paclitaxel to Gemcitabine)	8 of 78 (10.3%)	76 of 78 (97.4%)	Not reported
Crossover (Gemcitabine to Paclitaxel)	8 of 77 (10.4%)	73 of 77 (94.8%)	Not reported

Limitations and caveats (from the sponsor): Trial was designed with overall survival as primary endpoint. Enrollment was slower than expected. After 4 years, 919 patients were randomized and in August 2006, protocol was amended: primary endpoint was changed to progression free survival (PFS).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

55 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Paclitaxel and Carboplatin in people with Genital Neoplasms, Female and Fallopian Tube Neoplasms, run by Eli Lilly and Company at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Baseline to measured progressive disease or death up to 82 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00191646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011.