Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT00114218 | Completed Phase 2 Results

• 4 other identifiers: GOG-0130ENCI-2012-02680CDR0000434843U10CA027469
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0

  RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.

• Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

  Count of participants with Toxicities maximum grade greater than or equal to grade 3

  Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Study Arms (1)

Treatment (gemcitabine hydrochloride, docetaxel)

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Drug: Gemcitabine Hydrochloride; Drug: Docetaxel

Interventions

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdC, dFdCyd

Treatment (gemcitabine hydrochloride, docetaxel)

Docetaxel DRUG

Given IV

Also known as: TXT

Treatment (gemcitabine hydrochloride, docetaxel)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed uterine carcinosarcoma
• Malignant mixed Müllerian tumor, homologous or heterologous type
• Recurrent or persistent disease
• Progressive disease after prior local therapy
• 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 except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy
• Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma
• Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit normal (ULN)
• SGOT ≤ 2.5 times ULN

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Gemcitabine; Docetaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Linda Gedeon for Austin Miller, PhD.
• Organization: NRG Oncology

lgedeon@gogstats.org

716-845-1169

Study Officials

• Brigitte Miller

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2005
• First Posted: June 14, 2005
• Study Start: March 1, 2005
• Primary Completion: July 1, 2010
• Last Updated: January 8, 2019
• Results First Posted: October 16, 2018

Record last verified: 2014-12

Locations

US (1)