Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

This study has been terminated.
(Study was terminated due to lack of available funding.)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00331422
First received: May 30, 2006
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: paclitaxel
Procedure: cytoreductive surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Carboplatin and Paclitaxel as Neoadjuvant Chemotherapy Followed by Interval Cytoreduction in Women With Advanced Staged Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma for High-Risk Surgical Candidates or Patients Unlikely to be Optimally Surgically Cytoreduced

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy [ Time Frame: Week 18 (After 4 cycles of chemotherapy) ] [ Designated as safety issue: No ]
    These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.


Secondary Outcome Measures:
  • Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Week 16 (4 weeks after 4th course) ] [ Designated as safety issue: No ]
    Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.

  • Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration [ Time Frame: From Baseline to up to 12 weeks (4 courses of therapy) ] [ Designated as safety issue: No ]
    Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.

  • Change in Drug Resistance After Neoadjuvant Chemotherapy [ Time Frame: Day 1 to Time to Surgery (Approximately Week 18) ] [ Designated as safety issue: No ]
    As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.

  • Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density [ Time Frame: Week 18 (At surgery) ] [ Designated as safety issue: No ]
    Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.

  • Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy [ Time Frame: Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment) ] [ Designated as safety issue: No ]

    Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.

    Unable to evaluate; patients did not consistently complete the questionnaires.



Enrollment: 7
Study Start Date: October 2005
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients Who Received Treatment
All patients receiving treatment with Paclitaxel and Carboplatin followed by surgery to remove cancerous tissue.
Drug: carboplatin
Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.
Other Name: Paraplatin
Drug: paclitaxel
Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.
Other Name: Taxol
Procedure: cytoreductive surgery
Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis
Other Names:
  • surgery
  • debulking

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether at least 50% of patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer are able to achieve optimal cytoreduction (to < 1 centimeter of remaining disease) after neoadjuvant chemotherapy comprising paclitaxel and carboplatin.

Secondary

  • Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction.
  • Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy.
  • Determine how thrombospondin-1 (TSP-1), tumor protein 53 (p53), and tumor vessel density change after administration of neoadjuvant chemotherapy.
  • Assess the quality of life of patients receiving neoadjuvant chemotherapy.
  • Obtain estimates of tumor response after administration of neoadjuvant chemotherapy.
  • Determine whether serum cancer antigen 125 (CA-125) at the time of cytoreduction is associated with the ability to optimally reduce the patients.

OUTLINE: This is an open-label study.

Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the fourth course of chemotherapy, patients undergo interval cytoreductive surgery.

Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy.

Within 4 weeks after surgery, patients receive 2 additional courses of chemotherapy.

Quality of life is assessed periodically.

Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction. Tissue is examined by immunohistochemistry staining for p53, TSP-1, microvessel density (CD31), angiogenesis, membrane protein BCL-2, and multidrug resistant gene 1 (MDR-1). Gene array analysis and extreme drug resistant assays are also performed.

After completion of study treatment, patients are followed every 3 months for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma for which no previous treatment has been given.

Patients with the following histological epithelial cell types are eligible:

  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Transitional cell
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner's tumor

    • Measurable or non-measurable disease as defined by Solid Tumor Response Criteria (RECIST) within 4 weeks of study entry
    • High-risk surgical candidate
    • Gynecologic Oncology Group (GOG) performance status 0-3
    • Absolute neutrophil count ≥ 1,500/mm^3
    • Platelet count ≥ 100,000/mm^3
    • Creatinine ≤ 1.5 mg/dL
    • Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
    • Bilirubin ≤ 1.5 times ULN
    • Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times ULN
    • Life expectancy ≥ 12 weeks

Exclusion Criteria:

  • Pregnant or nursing
  • Positive pregnancy test -(Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment.)
  • History of another neoplasm except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery > 5 years prior to registration.
  • Septicemia, severe infection, acute hepatitis, or severe gastrointestinal bleeding, defined as requiring blood transfusion or hospitalization at registration
  • Unstable angina will not be eligible. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months.
  • History of severe hypersensitivity or allergic reaction to study drugs, drugs formulated in Cremophor EL^®, other platinol compounds, or mannitol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331422

Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Melissa A. Geller, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00331422     History of Changes
Other Study ID Numbers: 2004LS070, UMN-0409M64006, UMN- WCC-40
Study First Received: May 30, 2006
Results First Received: November 23, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer
Brenner tumor

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014