A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma

NCT00231868 | Completed Phase 2 Results DMC

• 1 other identifier: 01-09-227
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities. Given these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.

Conditions

Uterine Cancer

Keywords

Uterine Papillary Serous Carcinoma; UPSC; Radiation Therapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC

  Overall survival analysis of early stage (stage 1 \& 2) and late stage (stage 3 \& 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS).

  Up to 7 years

Study Arms (1)

A

EXPERIMENTAL

Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy

Drug: Carboplatin and Paclitaxel and Pelvic Radiation Therapy; Procedure: Carboplatin and Paclitaxel and Pelvic Radiation Therapy; Drug: Carboplatin and Paclitaxel and Radiation Therapy

Interventions

Carboplatin and Paclitaxel and Pelvic Radiation Therapy DRUG

Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles

A

Carboplatin and Paclitaxel and Radiation Therapy DRUG

Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease.
• Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings.
• Age \> 18 years.
• ECOG performance status of \< 2.
• Written voluntary informed consent.

You may not qualify if:

• Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
• Serum SGOT and /or SGPT \> 2.5 times the institutional upper limit of normal
• Total serum bilirubin \> 1.5 mg/dl
• History of chronic or active hepatitis
• Serum creatinine \> 2.0 mg/dl
• Platelets \< 100,000/mm3
• Absolute neutrophil count (ANC) \< 1500/mm3
• Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
• Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
• Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
• Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Einstein MH, Frimer M, Kuo DY, Reimers LL, Mehta K, Mutyala S, Huang GS, Hou JY, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. Gynecol Oncol. 2012 Jan;124(1):21-5. doi: 10.1016/j.ygyno.2011.10.007. Epub 2011 Oct 27.

  PMID: 22035806 RESULT

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Limitations and Caveats

There are minor differences in the carboplatin doses between the current trial and our pilot study. This is a single institution trial. A limited number of advanced stage patients was accrued.

Results Point of Contact

• Title: Dr. Dennis Yi-Shin Kuo
• Organization: Montefiore Medical Center

DYKUO@montefiore.org

718-405-8082

Study Officials

• Mark H Einstein, M.D., M.S.

  Montefiore Medical Center and Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: December 1, 2001
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Locations

US (1)