Endometrial AdenocarcinomaPhase 1NCT00005830
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
A Phase 1 study testing Doxorubicin Hydrochloride, Cisplatin and Radiation Therapy in people with Endometrial Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma
- What is being tested?
- Doxorubicin Hydrochloride, Cisplatin and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed endometrial cancer including 1 of the following subtypes:
- Clear cell carcinoma
- Serous papillary carcinoma
- Endometrioid adenocarcinoma
- Stage III or IV disease
- Positive adnexa
Show all 29Show fewer
- Metastases to serosa, bowel mucosa, abdomen
- Positive pelvic or paraaortic nodes
- Positive pelvic washings or vaginal involvement within the radiation port
- Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
- Must have had a hysterectomy and bilateral salpingo oophorectomy
- No recurrent disease
- No distant metastases outside of abdominopelvic area, including:
- Parenchymal liver metastases
- Lung metastases
- Positive inguinal lymph nodes
- Positive supraclavicular nodes
- Pleural effusion with malignant cytology
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and alkaline phosphatase no greater than 3 times ULN
- Creatinine no greater than ULN
- Cardiac ejection fraction greater than 50%
- No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
- No prior chemotherapy
- No prior pelvic or abdominal radiotherapy
- No prior radiotherapy for other prior malignancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.
II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.
- Conditions
- Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
- Being tested
- Doxorubicin Hydrochloride, Cisplatin, Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given IV
CisplatinDrug
Given IV
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (doxorubicin, cisplatin, radiation therapy) | Experimental | Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks. Receives: Drug: Doxorubicin Hydrochloride; Drug: Cisplatin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients completing the prescribed therapy
Measured: Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Measured: 3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Measured: Up to 5 years after completion of study treatment
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
Measured: Up to 9 weeks
Secondary outcomes (1)
Reason for discontinuing study therapy
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2000
- Primary completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Fowler, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005830
- Sponsor's protocol ID
- GOG-9908
- Other IDs
- NCI-2012-02332, CDR0000067844, GOG-9908, GOG-9908, U10CA027469
- Status last verified
- Dec 2014
- First submitted
- 2 Jun 2000
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00005830
- Acronym / sponsor ID
- GOG-9908
- Conditions
- Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Jul 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
Detailed description
OBJECTIVES:
- Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.
II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (doxorubicin, cisplatin, radiation therapy) | Experimental | Drug: Doxorubicin Hydrochloride, Drug: Cisplatin, Radiation: Radiation TherapyPatients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically confirmed endometrial cancer including 1 of the following subtypes:
- Stage III or IV disease
- Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
- No recurrent disease
- No distant metastases outside of abdominopelvic area, including:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Doxorubicin HydrochlorideGiven IV | Drug | Treatment (doxorubicin, cisplatin, radiation therapy) |
| CisplatinGiven IV | Drug | Treatment (doxorubicin, cisplatin, radiation therapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo radiation therapy | Radiation | Treatment (doxorubicin, cisplatin, radiation therapy) |
Primary outcome
Number of patients completing the prescribed therapy
Time frame: Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Time frame: 3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Time frame: Up to 5 years after completion of study treatment
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
Time frame: Up to 9 weeks
1 secondary outcome
Reason for discontinuing study therapy
Time frame: Up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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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.
Jeffrey Fowler principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicin Hydrochloride, Cisplatin and Radiation Therapy in people with Endometrial Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, run by Gynecologic Oncology Group at 1 site in United States.
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 29 inclusion and 0 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients completing the prescribed therapy (time frame: Up to 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2014.