Expired Study
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New Britain, Connecticut 06050


Purpose:

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.


Study summary:

OBJECTIVES: - Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma. - Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor) - Stage III or IV disease - Persistent or recurrent disease - Documented disease progression - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - At least 1 target lesion - Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression - Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count ≥ 100,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No sensory or motor neuropathy > grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy for uterine sarcoma Endocrine therapy - At least 1 week since prior hormonal therapy for uterine sarcoma - Concurrent hormone replacement therapy allowed Radiotherapy - See Disease Characteristics Surgery - Not specified Other - Recovered from all prior therapy - No prior anticancer therapy that would preclude study therapy


Study is Available At:


Original ID:

CDR0000432956


NCT ID:

NCT00112489


Secondary ID:

GOG-0232B


Study Acronym:


Brief Title:

Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer


Official Title:

A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

55


Enrollment Type:

Actual


Overall Contact Information

Official Name:Matthew A. Powell, MD
Study Chair
Washington University Siteman Cancer Center

Study Dates

Start Date:May 2005
Primary Completion Date:July 2010
Primary Completion Type:Actual
Verification Date:April 2014
Last Changed Date:August 27, 2018
First Received Date:June 2, 2005
First Results Date:April 11, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Nature and Degree of Toxicity
Time Frame:During study treatment and up to 30 days after stopping study treatment
Safety Issues:False
Description:Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Outcome Type:Primary Outcome
Measure:Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Time Frame:Response was measured every other cycle (q 6 weeks) until disease progression is documented.
Safety Issues:False
Description:Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression

Study Interventions

Intervention Type:Drug
Name:carboplatin
Arm Name:Taxol-Carbo
Intervention Type:Drug
Name:paclitaxel
Arm Name:Taxol-Carbo

Study Arms

Study Arm Type:Experimental
Arm Name:Taxol-Carbo
Description:Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Powell MA, Filiaci VL, Rose PG, Mannel RS, Hanjani P, Degeest K, Miller BE, Susumu N, Ueland FR. Phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. J Clin Oncol. 2010 Jun 1;28(16):2727-31. doi: 10.1200/JCO.2009.26.8326. Epub 2010 Apr 26.
PMID:20421537

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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