Clinical trial · Interventional

Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer

Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma

NCT00006903CI-TRIAL-00037710unknownPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent Uterine Corpus Carcinoma	—	UNRESOLVED	—
Stage III Uterine Corpus Cancer AJCC v7	Malignant Uterine Corpus Neoplasm	CURATED_BROADER	0.78
Stage IV Uterine Corpus Cancer AJCC v7	Malignant Uterine Corpus Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Fulvestrant	Drug	Fulvestrant	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment (fulvestrant)
description
Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
interventionNames
1. Drug: Fulvestrant

Primary outcomes (2)

measure
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks
timeFrame
Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.
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 is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is 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 nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Criteria:

* Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that is not curable with surgery or radiotherapy
* Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

  * ER positive or negative allowed
* Measurable disease:

  * At least 1 target lesion not within a previously irradiated field OR irradiated target lesion with clear disease progression
  * At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, MRI, OR at least 10 mm by spiral CT scan
* Performance status:

  * GOG 0-1
* Hematopoietic:

  * Absolute neutrophil count \>= 1,500/mm\^3
  * Platelet count \>= 100,000/mm\^3
  * No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor deficiency, or requirement for anticoagulants)
* Hepatic:

  * Bilirubin =\< 1.5 times upper limit of normal (ULN)
  * SGOT =\< 3 times ULN
  * Alkaline phosphatase =\< 3 times ULN
* Renal:

  * Creatinine =\< 2 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to castor oil
* No other concurrent malignancy except nonmelanoma skin cancer
* No other prior malignancy within past 5 years
* No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer
* No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that has subsequently recurred
* At least 3 weeks since prior hormonal therapy and recovered
* At least 3 weeks since prior radiotherapy and recovered
* At least 3 weeks since prior surgery and recovered

References

Publications (0)

Data not yet available

No reference posted for this study.