Papillary Serous Carcinoma of the Endometrium

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00515073
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Duration (Months): 145
• Patients Per Site: 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objectives:

• To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival.

• To evaluate the toxicity of Paclitaxel and pelvic radiation.

• To collect and evaluate patients' quality of life/symptom assessment data.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: Paclitaxel; Radiation: Pelvic Radiation; Drug: Dexamethasone; Drug: Cimetidine; Drug: Diphenhydramine	Phase 2

Detailed Description

Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.

If you are found to be eligible to take part in this study, you will begin treatment. You will have radiation treatment to your pelvis (hip area) every day (Monday - Friday) for a total of 25 treatments. Each treatment should take about 20 minutes to complete.

After the radiation treatment, you will receive a type of radiation called a "vaginal cuff boost." The vaginal cuff boost involves a small device being inserted into the vagina to treat the back of the vagina with a high dose of radiation. The applicator is similar to placing a large tampon in the vagina. This internal treatment takes about 30 minutes for each treatment. This is separate from the external radiation treatments that are given.

While you are receiving radiation treatment, and then afterwards, you will also receive chemotherapy with paclitaxel. During the radiation period, you will receive paclitaxel by vein over 1 hour, on Days 1, 8, 15, 22, and 29. Starting 4-6 weeks after radiation treatment is finished, you will receive paclitaxel at a larger dose, given over 3 hours each time, once every 21 days (3 weeks). You will receive up to 4 "cycles" of chemotherapy, each cycle lasting 21 days.

You will be given certain drugs about 30 minutes before your chemotherapy treatments to help control possible side effects, like allergic reactions. These drugs include dexamethasone, diphenhydramine (Benadryl), and cimetidine.

You will have several tests performed throughout the study. Before each cycle of chemotherapy and one month after the last cycle of chemotherapy is given, quality of life and symptom assessment forms will be completed. These questionnaires should only take about 15 minutes to complete.

While you are on chemotherapy treatment, you will have tests performed before each chemotherapy treatment. This will involve blood (about 1 tablespoon) drawn for routine tests, and a review of your symptoms by the study staff.

Once you are off study treatment, you will be asked to return to the clinic for follow-up visits. These visits will occur every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year after that. At these visits, you will have a physical and pelvic exam performed, along with blood (about 1 tablespoon) drawn for routine tests. Chest x-rays will usually be done once a year and any other diagnostic exams will only be done if your doctor thinks they are needed.

This is an investigational study. There are no standard treatments for this type of endometrial cancer, but radiation and chemotherapy are common treatments. This combination of chemotherapy and radiation is considered experimental. Up to 49 patients will take part in this multicenter study. Up to 44 participants will be enrolled at M. D. Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium
• Study Start Date: Apr 1, 2001
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Paclitaxel (Taxol) + Pelvic Radiation Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.

Drug: Paclitaxel; 50 mg/m^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.; Other Names: Taxol ; Radiation: Pelvic Radiation; Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.; Drug: Dexamethasone; 20 mg IV given 30 minutes prior to chemotherapy; Drug: Cimetidine; 300 mg IV given 30 minutes prior to chemotherapy; Drug: Diphenhydramine; 50 mg IV given 30 minutes prior to chemotherapy

Outcome Measures

Primary Outcome Measures

1. Overall Survival at 2 Years and 5 Years [Assessment at 2 years and 5 years]

   The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient must undergo surgical staging within 8 weeks of study entry.

2. Patients with mixed histology tumor that include a papillary serous component are eligible.

3. Only patients with non-measurable disease can be entered.

4. Patients may not have had previous chemotherapy or radiation therapy.

5. Patients must have an estimated life expectancy of 12 weeks or greater.

6. Patients must have a Zubrod performance status of less than or equal to 2.

7. Patients must have adequate bone marrow, renal and hepatic function: with white blood count (WBC) greater than or equal to 3000; Absolute neutrophil count (ANC) greater than or equal to 1500; Platelets greater than or equal to 100,000; glutamic-pyruvic transaminase (SGPT) less than or equal to 2 times the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl.

8. Patients must sign an institutionally approved consent form

Exclusion Criteria:

1. Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.

2. Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).

3. Patients who have a history of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years.

4. Patients with a Zubrod status of 3 or greater.

5. Patients with an active infection.

6. Patients with serious intercurrent medical illness.

7. Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M. D. Anderson Cancer Center - Orlando	Orlando	Florida	United States	32806
2	UT MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Anuja Jhingran, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00515073
• Other Study ID Numbers: ID00-418
• First Posted: Aug 13, 2007
• Last Update Posted: Jul 3, 2014
• Last Verified: May 1, 2014

• Keywords provided by M.D. Anderson Cancer Center: Endometrial Cancer; Papillary Serous Carcinoma; Pelvic Radiation Therapy; Paclitaxel; Taxol
• Additional relevant MeSH terms: Carcinoma; Endometrial Neoplasms; Cystadenocarcinoma, Serous; Diphenhydramine; Promethazine; Dexamethasone; Paclitaxel; Cimetidine

Study Results

Participant Flow

Recruitment Details	Recruitment Period: April 30, 2001 to November 18, 2009 with actual enrollment occuring October 2001 through July 2009 at University of Texas (UT) MD Anderson Cancer Center and MD Anderson Cancer Center Orlando.
Pre-assignment Detail	Two participants of 32 were enrolled but not included in group assignment due to ineligibility.

Arm/Group Title	Paclitaxel (Taxol) + Pelvic Radiation
Arm/Group Description	Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
Period Title: Overall Study
STARTED	30
COMPLETED	28
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Paclitaxel (Taxol) + Pelvic Radiation
Arm/Group Description	Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
Overall Participants	30
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63
Sex: Female, Male (Count of Participants)
Female	30 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival at 2 Years and 5 Years
Description	The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.
Time Frame	Assessment at 2 years and 5 years

Outcome Measure Data

Analysis Population Description

Two participants were inevaluable.

Arm/Group Title	Paclitaxel (Taxol) + Pelvic Radiation
Arm/Group Description	Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
Measure Participants	28
2 Years	93 310%
5 Years	85 283.3%

Adverse Events

Time Frame	Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
Arm/Group Title	Paclitaxel (Taxol) + Pelvic Radiation
Arm/Group Description	Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.
All Cause Mortality
	Paclitaxel (Taxol) + Pelvic Radiation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel (Taxol) + Pelvic Radiation
	Affected / at Risk (%)	# Events
Total	15/30 (50%)
Blood and lymphatic system disorders
GRANULOCYTOPENIA	1/30 (3.3%)	1
Gastrointestinal disorders
NAUSEA	5/30 (16.7%)	5
VOMITING	1/30 (3.3%)	1
DIARRHEA	13/30 (43.3%)	13
General disorders
FATIGUE	10/30 (33.3%)	10
PAIN, ABDOMEN	2/30 (6.7%)	2
PAIN, CHEST	1/30 (3.3%)	1
Infections and infestations
INFECTION	2/30 (6.7%)	2
Metabolism and nutrition disorders
DEHYDRATION	1/30 (3.3%)	1
ANOREXA	5/30 (16.7%)	5
Musculoskeletal and connective tissue disorders
MYALGIA	2/30 (6.7%)	2
PAIN, BONE	3/30 (10%)	3
Nervous system disorders
HEADACHE	2/30 (6.7%)	2
Psychiatric disorders
ANXIETY	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNEA	6/30 (20%)	7
Other (Not Including Serious) Adverse Events
	Paclitaxel (Taxol) + Pelvic Radiation
	Affected / at Risk (%)	# Events
Total	19/30 (63.3%)
Blood and lymphatic system disorders
GRANULOCYTOPENIA	3/30 (10%)	3
LEUKOPENIA	9/30 (30%)	9
ANEMIA	9/30 (30%)	9
Gastrointestinal disorders
CONSTIPATION	2/30 (6.7%)	3
DIARRHEA	8/30 (26.7%)	12
MUCOSITIS (CLINICAL EXAM) ORAL CAVITY	2/30 (6.7%)	2
NAUSEA	3/30 (10%)	7
Vomiting	2/30 (6.7%)	5
ANOREXIA	4/30 (13.3%)	4
RECTAL BLEEDING	2/30 (6.7%)	2
General disorders
FATIGUE	7/30 (23.3%)	9
MYALGIA	5/30 (16.7%)	11
PAIN (ABDOMEN NOS)	2/30 (6.7%)	6
PAIN	2/30 (6.7%)	2
RIGORS, CHILLS	2/30 (6.7%)	2
Infections and infestations
INFECTION	2/30 (6.7%)	2
Investigations
FEVER WITHOUT NEUTROPENIA	2/30 (6.7%)	2
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH	2/30 (6.7%)	2
HYPOKALEMIA	4/30 (13.3%)	4
HYPOMAGNESEMIA	2/30 (6.7%)	2
Musculoskeletal and connective tissue disorders
MOTOR SKILL	4/30 (13.3%)	4
Nervous system disorders
HEADACHE	4/30 (13.3%)	4
NEUROPATHY	16/30 (53.3%)	16
Skin and subcutaneous tissue disorders
DIAPHORESIS	3/30 (10%)	3
ALOPECIA	2/30 (6.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.