Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

NCT00093496 | Completed Phase 2 Results

• 8 other identifiers: NCI-2009-00052CDR0000388036NCI-6307MAYO-MC0362MC03626307P30CA015083N01CM62205
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.

  Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline.

  Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

Secondary Outcomes (3)

• Times to Progression

  Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.

• Overall Survival

  Every 3 months until disease progression and then every 6 months for up to 5 years.

• Toxicity

  Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Drug: gemcitabine hydrochloride; Drug: tanespimycin

Interventions

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (chemotherapy)

tanespimycin DRUG

Given IV

Also known as: 17-AAG

Treatment (chemotherapy)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
• Relapsed disease
• Persistent disease
• Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:
• Failure to obtain a complete response to initial platinum therapy
• Recurrence \< 6 months after completing a platinum-containing regimen for initial or recurrent disease
• Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
• Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
• Measurable or evaluable disease
• Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
• Patients with accessible disease must be willing to undergo tumor biopsies
• No CNS metastases
• Performance status - ECOG 0-2
• WBC ≥ 3,000/mm\^3
• Platelet count ≥ 100,000/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Gemcitabine; tanespimycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Charles Erlichman, M.D.
• Organization: Mayo Clinic Cancer Center

erlichman.charles@mayo.edu

Study Officials

• Paul Haluska

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: October 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2012
• Last Updated: May 20, 2014
• Results First Posted: July 10, 2013

Record last verified: 2011-10

Locations

US (1)