Clinical trial · Observational

Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas

NCT00897039CI-TRIAL-00012245unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment. PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

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
Fallopian Tube Cancer	Malignant Fallopian Tube Neoplasm	ALIAS	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Primary Peritoneal Cavity Cancer	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
flow cytometry	Other	—	UNRESOLVED
immunohistochemistry staining method	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

[]

Primary outcomes (1)

measure
Correlation of a statistically significant discriminator of sensitivity with complete response rate

Eligibility

Eligibility (as posted)

Sex: Female

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Pathologically confirmed adenocarcinoma of 1 of the following types:

  * Ovarian
  * Primary peritoneal
  * Fallopian tube
* Must meet 1 of the following criteria:

  * De novo malignancy with no prior chemotherapy
  * Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols
* Tumor must be accessible for biopsy or drainage of effusions
* Chemotherapy is considered a treatment option
* No symptomatic or uncontrolled parenchymal brain metastases
* No meningeal metastasis

PATIENT CHARACTERISTICS:

* Not pregnant
* Negative pregnancy test
* Fertile patients must agree to use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2006
Primary completion: —
Completion: —
First posted: May 12, 2009
Last update posted: Sep 20, 2013
Enrollment: 60 (estimated)
Lead sponsor: Southeastern Gynecologic Oncology OTHER
Keywords: ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent primary peritoneal cavity cancer, stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer, stage IIB primary peritoneal cavity cancer, stage IIC primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, recurrent fallopian tube cancer, stage IA fallopian tube cancer, stage IB fallopian tube cancer, stage IC fallopian tube cancer, stage IIA fallopian tube cancer, stage IIB fallopian tube cancer, stage IIC fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer