Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin

NCT00369954 | Withdrawn Phase 2

• 2 other identifiers: CDR0000496764GOG-0102H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, 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) and giving them in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Relative risk of progression-free survival

• Frequency and severity of observed adverse effects by CTCAE version 3.0

Secondary Outcomes (1)

• Relative risk of survival

Interventions

carboplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer * Persistent or recurrent disease * Nonmeasurable disease * Platinum-sensitive disease * Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen * Patients with partial response or disease progression after first-line therapy are not eligible * No disease recurrence within 6 months after completion of first-line platinum-taxane therapy * Must have undergone laparoscopy or laparotomy for either of the following: * Second-look surgery after a complete response to first-line therapy * No negative second-look surgery * Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy * No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis * Disease must be confined to the peritoneal cavity * Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed * Not a candidate for a higher priority GOG protocol * No tumors of low malignant potential PATIENT CHARACTERISTICS: * GOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Neuropathy (sensory and motor) ≤ grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other invasive malignancies within the past 5 years except nonmelanoma skin cancer * No extensive intra-abdominal adhesions PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery or chemotherapy * No prior intraperitoneal therapy * No prior gemcitabine hydrochloride * No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer * No radiotherapy to \> 25% of marrow-bearing areas * No prior abdominal-pelvic radiotherapy * No prior cancer treatment that would preclude study therapy * No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy * Concurrent hormone replacement therapy allowed * No concurrent amifostine or other protective reagents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Gemcitabine

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Noelle G. Cloven, MD

  Methodist Estabrook Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 30, 2006
• Study Start: April 1, 2006
• Last Updated: June 10, 2013

Record last verified: 2007-10