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

NCT00331422 | Terminated Phase 2 Results DMC

• 3 other identifiers: 2004LS070UMN-0409M64006UMN- WCC-40
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy

  These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.

  Week 18 (After 4 cycles of chemotherapy)

Secondary Outcomes (5)

• Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)

  Week 16 (4 weeks after 4th course)

• Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration

  From Baseline to up to 12 weeks (4 courses of therapy)

• Change in Drug Resistance After Neoadjuvant Chemotherapy

  Day 1 to Time to Surgery (Approximately Week 18)

• Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density

  Week 18 (At surgery)

• Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy

  Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)

Study Arms (1)

Patients Who Received Treatment

EXPERIMENTAL

All patients receiving treatment with Paclitaxel and Carboplatin followed by surgery to remove cancerous tissue.

Drug: carboplatin; Drug: paclitaxel; Procedure: cytoreductive surgery

Interventions

carboplatin DRUG

Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.

Also known as: Paraplatin

Patients Who Received Treatment

paclitaxel DRUG

Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.

Also known as: Taxol

Patients Who Received Treatment

cytoreductive surgery PROCEDURE

Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis

Also known as: surgery, debulking

Patients Who Received Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Brenner Tumor

Interventions

Carboplatin; Paclitaxel; Cytoreduction Surgical Procedures; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

1 of the 2 evaluable patients was switched from Paclitaxel to Taxotere during the course of her treatment due to toxicity (adverse effects), but since it remains a platinum-based chemotherapy she is included in the evaluable group.

Results Point of Contact

• Title: Melissa Geller, MD
• Organization: Masonic Cancer Center, University of Minnesota

gelle005@umn.edu

612-626-3111

Study Officials

• Melissa A. Geller, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: December 28, 2017
• Results First Posted: February 8, 2010

Record last verified: 2017-12

Locations

US (1)